LEEP REDIKIT- mepivacaine hydrochloride, lidocaine hydrochloride, epinephrine bitartrate, iodine, potassium iodide, ferric subsulfate kit

1. No Title 1572555520
2. No Title 1572453463
3. Description
4. Clinical Pharmacology
5. Indications And Usage
6. Contraindications
7. Warnings
8. Precautions
9. Adverse Reactions
10. Overdosage
11. Dosage And Administration
12. Maximum Recommended Dosages
13. Sterilization, Storage And Technical Procedures
14. How Supplied
15. Contents
16. Description
17. How Supplied
18. Indications And Usage
19. Administration
20. Caution
21. Storage
22. Disposal
23. Actions & Uses
24. Storage
25. Disposal
26. References
27. Principal Display Panel

No Title 1572555520 ⮝

LEEP KIT-CooperSurgical NDC # 59365-6061-1 P/N 6061 [5 Pack]
Drug Content per Each kit:
1 Vial Xylocaine [Lidocaine HCl 1%] 10 ml with Epinephrine, 10 mL (1:100,000)
NDC Code: 63323-482-17 Labeler: Fresenius Kabi USA, LLC
Manufacturer: APP Pharmaceuticals, LLC

1 Lugol s (strong iodine solution, USP), 8 mL Single Dose
NDC Code: 59365-6064-0 Labeler: CooperSurgical Inc.
Manufacturer: Ecometrics Inc. [CT]

1 AstrinGYN (ferric subsulfate), 8 gm Single Dose
NDC Code: 59365-6065-0 Labeler: CooperSurgical Inc.
Manufacturer: Ecometrics Inc. [CT]



Xylocaine
For Infiltration and Nerve Block
Rx only

No Title 1572453463 ⮝

LEEP KIT-CooperSurgical NDC # 59365-6061-1 P/N 6061 [5 Pack]
Drug Content per Each kit:
1 Vial Xylocaine [Lidocaine HCl 1%] 10 ml with Epinephrine, 10 mL (1:100,000)
NDC Code: 63323-482-17 Labeler: Fresenius Kabi USA, LLC
Manufacturer: APP Pharmaceuticals, LLC

1 Lugol s (strong iodine solution, USP), 8 mL Single Dose
NDC Code: 59365-6064-0 Labeler: CooperSurgical Inc.
Manufacturer: Ecometrics Inc. [CT]

1 AstrinGYN (ferric subsulfate), 8 gm Single Dose
NDC Code: 59365-6065-0 Labeler: CooperSurgical Inc.
Manufacturer: Ecometrics Inc. [CT]



Xylocaine
For Infiltration and Nerve Block
Rx only

Description ⮝

AstrinGyn (Ferric Subsulfate, Aqueous).

Clinical Pharmacology ⮝

Mechanism of Action

Lidocaine HCl stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses thereby effecting local anesthetic action.

Hemodynamics

Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. With central neural blockade these changes may be attributable to block of autonomic fibers, a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system, and/or the beta-adrenergic receptor stimulating action of epinephrine when present. The net effect is normally a modest hypotension when the recommended dosages are not exceeded.

Pharmacokinetics and Metabolism

Information derived from diverse formulations, concentrations and usages reveals that lidocaine HCl is completely absorbed following parenteral administration, its rate of absorption depending, for example, upon various factors such as the site of administration and the presence or absence of a vasoconstrictor agent. Except for intravascular administration, the highest blood levels are obtained following intercostal nerve block and the lowest after subcutaneous administration.

The plasma binding of lidocaine HCl is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg of free base per mL 60 to 80 percent of lidocaine HCl is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein.

Lidocaine HCl crosses the blood-brain and placental barriers, presumably by passive diffusion.

Lidocaine HCl is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine HCl. Approximately 90% of lidocaine HCl administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline.

The elimination half-life of lidocaine HCl following an intravenous bolus injection is typically 1.5 to 2 hours. Because of the rapid rate at which lidocaine HCl is metabolized, any condition that affects liver function may alter lidocaine HCl kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine HCl kinetics but may increase the accumulation of metabolites.

Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine HCl required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 mcg free base per mL. In the rhesus monkey arterial blood levels of 18 to 21 mcg/mL have been shown to be threshold for convulsive activity.

Indications And Usage ⮝

Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.

Contraindications ⮝

Iodide preparations are contraindicated in patients with known sensitivity to the drugs.

Warnings ⮝

For External Use Only. Should inadvertent ocular administration occur, the eye(s) should be washed immediately with large amounts of water or normal saline, occasionally lifting the upper and lower lids until no evidence of solution remains (approximately 15-20 minutes).

Precautions ⮝

As with all iron solutions applied to dermal surfaces denuded of epithelium or to mucous membranes, topical application of AstrinGyn (ferric subsulfate) may result in hyperpigmentation ( tattooing ).3, 4

Microscopically, this hyperpigmentation may be observed as ferrugination of collagen fibers and fibrin.5 In one study of uterine cervical tissue, ferric subsulfate solution penetrated denuded mucosa and produced coagulation necrosis to a maximum depth of 0.6 mm.6In an in vitro study, ferric subsulfate solution produced a radiopacity with a density intermediate between that of water/tissue and calcium.7Should a re-biopsy of the same lesion be required, pathologists and other physicians involved in the care of the patient should be aware of the previous use of ferric subsulfate solution. Previous use of ferric subsulfate solution may result in a histologic artifact upon re-biopsy of heavy pigmentation, similar to hemosiderin, together with shrinkage and discoloration of collagen bundles.8, 9 Similarly, previous use of ferric subsulfate solution may result in a radiographic artifact.

Adverse Reactions ⮝

Systemic

Adverse experiences following the administration of lidocaine HCl are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported:

Central Nervous System

CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness following the administration of lidocaine HCl is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.

Cardiovascular System

Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.

Allergic

Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to local anesthetic agents or to the methylparaben used as a preservative in the multiple dose vials. Allergic reactions as result of sensitivity to lidocaine HCl are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Neurologic

The incidences of adverse reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration and the physical status of the patient. In a prospective review of 10,440 patients who received lidocaine HCl for spinal anesthesia, the incidences of adverse reactions were reported to be about 3 percent each for positional headaches, hypotension and backache; 2 percent for shivering; and less than 1 percent each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision. Many of these observations may be related to local anesthetic techniques, with or without a contribution from the local anesthetic.

In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter may occur. Subsequent adverse effects may depend partially on the amount of drug administered subdurally. These may include spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control, and loss of perineal sensation and sexual function. Persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months) or incomplete recovery have been reported in rare instances when caudal or lumbar epidural block has been attempted. Backache and headache have also been noted following use of these anesthetic procedures.

There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar administration.

Overdosage ⮝

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (see ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS).

Management of Local Anesthetic Emergencies

The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient s state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered.

The first step in the management of convulsions, as well as underventilation or apnea due to unintended subarachnoid injection of drug solution, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to the use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (eg, ephedrine).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. Underventilation or apnea due to unintentional subarachnoid injection of local anesthetic solution may produce these same signs and also lead to cardiac arrest if ventilatory support is not instituted. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.

Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated.

Dialysis is of negligible value in the treatment of acute overdosage with lidocaine HCl.

The oral LD50 of lidocaine HCl in non-fasted female rats is 459 (346 to 773) mg/kg (as the salt) and 214 (159 to 324) mg/kg (as the salt) in fasted female rats.

Dosage And Administration ⮝

Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required, only solutions containing epinephrine should be used except in those cases where vasopressor drugs may be contraindicated.

There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Xylocaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for the elderly and debilitated patients and patients with cardiac and/or liver disease.

The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (ie, total dose) of local anesthetic used. Thus, an increase in volume and concentration of Xylocaine Injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Xylocaine Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine HCl is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.

For intravenous regional anesthesia, only the 50 mL single dose vial containing Xylocaine (lidocaine HCl) 0.5% Injection should be used.

Epidural Anesthesia

For epidural anesthesia, only the following dosage forms Xylocaine Injection are recommended:

1% without epinephrine 10 mL Plastic Ampule

1% without epinephrine 30 mL single dose solutions

1% with epinephrine 1:200,000 30 mL single dose solutions

1.5% without epinephrine 10 mL Plastic Ampule

1.5% without epinephrine 20 mL Plastic Ampule

1.5% with epinephrine 1:200,000 30 mL ampules, 30 mL single dose solutions

2% without epinephrine 10 mL Plastic Ampule

2% with epinephrine 1:200,000 20 mL ampules, 20 mL single dose solutions

Although these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block, provided they are employed as single dose units. These solutions contain no bacteriostatic agent.

In epidural anesthesia, the dosage varies with the number of dermatomes to be anesthetized (generally 2 to 3 mL of the indicated concentration per dermatome).

Caudal and Lumbar Epidural Block

As a precaution against the adverse experience sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2 to 3 mL of 1.5% lidocaine HCl should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose (10 to 15 mcg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient epinephrine response within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of Xylocaine Injection through the catheter should be avoided, and, when feasible, fractional doses should be administered.

In the event of the known injection of a large volume of local anesthetic solution into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter.

Maximum Recommended Dosages ⮝

Adults

For normal healthy adults, the individual maximum recommended dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) of body weight, and in general it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine the maximum individual dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight, and in general it is recommended that the maximum total dose does not exceed 300 mg. For continuous epidural or caudal anesthesia, the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, more drug may be administered if required to produce adequate anesthesia.

The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients and non-obstetrical patients is 200 mg total. One half of the total dose is usually administered to each side. Inject slowly, five minutes between sides (see also discussion of paracervical block in PRECAUTIONS).

For intravenous regional anesthesia, the dose administered should not exceed 4 mg/kg in adults.

Children

It is difficult to recommend a maximum dose of any drug for children, since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child s age and weight. For example, in a child of 5 years weighing 50 lbs the dose of lidocaine HCl should not exceed 75 to 100 mg (1.5 to 2 mg/lb). The use of even more dilute solutions (ie, 0.25 to 0.5%) and total dosages not to exceed 3 mg/kg (1.4 mg/lb) are recommended for induction of intravenous regional anesthesia in children.

In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. In some cases it will be necessary to dilute available concentrations with 0.9% sodium chloride injection in order to obtain the required final concentration.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. The Injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

Table 1: Recommended Dosages

Procedure	Xylocaine (lidocaine hydrochloride) Injection (without epinephrine)
	Conc (%)	Vol (mL)	Total Dose (mg)
Infiltration
Percutaneous	0.5 or 1	1 to 60	5 to 300
Intravenous regional	0.5	10 to 60	50 to 300
Peripheral Nerve Blocks, eg,
Brachial	1.5	15 to 20	225 to 300
Dental	2	1 to 5	20 to 100
Intercostal	1	3	30
Paravertebral	1	3 to 5	30 to 50
Pudendal (each side)	1	10	100
Paracervical
Obstetrical analgesia (each side)	1	10	100
Sympathetic Nerve Blocks, eg,
Cervical (stellate ganglion)	1	5	50
Lumbar	1	5 to 10	50 to 100
Central Neural Blocks
Epidural*
Thoracic	1	20 to 30	200 to 300
Lumbar
Analgesia	1	25 to 30	250 to 300
Anesthesia	1.5	15 to 20	225 to 300
	2	10 to 15	200 to 300
Caudal
Obstetrical analgesia	1	20 to 30	200 to 300
Surgical anesthesia	1.5	15 to 20	225 to 300
*Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome).

THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY AS A GUIDE. OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL MAXIMUM RECOMMENDED DOSE IS NOT EXCEEDED.

Sterilization, Storage And Technical Procedures ⮝

Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc) should not be used for skin or mucous membrane disinfection as they have been related to incidents of swelling and edema. When chemical disinfection of multi-dose vials is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of USP grade, contain denaturants which are injurious to rubber and therefore are not to be used.

Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free (MPF).

How Supplied ⮝

8 gm single-use glass bottles.

Contents ⮝

Ferric subsulfate 259mg/g [0.0638gm Fe 3+/ml]. Preserved with benzalkonium chloride 0.005%. Povidone USP 23.2%. Glycerin USP 13.3%. Purified Water USP.

Description  ⮝

LUGOL S is an aqueous solution containing Iodine 5%, and potassium iodide 10%, w/v (LUGOL s Solution). LUGOL s is a transparent liquid with a deep brown color and the odor of iodine.

How Supplied  ⮝

LUGOL S is supplied in 8 ml glass single-use bottles.

Indications And Usage  ⮝

LUGOL s is a topical antiseptic. Strong Iodine Solution is a germicide and fungicide. LUGOL s is preservative-free.

Administration  ⮝

LUGOL S is applied directly to areas needing antiseptic.

Caution ⮝

Federal law (USA) prohibits dispensing without a prescription.

Storage  ⮝

Keep tightly closed. Protect from light. DO NOT use if seal has been broken. Store at controlled room temperature 15 -30 C (59 -86 F).

Disposal  ⮝

Opened containers with unused portions of product and applicator swabs containing residual product should be placed in a suitable, dry container for disposal following local hazardous waste practices. Waste containing LUGOL S should not be subjected to any thermal process whether intended for destruction or recycling purposes.



AstrinGyn
(Ferric Subsulfate, Aqueous)
REF 6065

Actions & Uses ⮝

AstrinGyn is a styptic agent used for achieving local hemostasis. In punch biopsies of the full dermis, the time to achieve hemostasis is typically less than 20 seconds.1 One method for applying ferric subsulfate solution for dermal use consists of the physician placing fingers at the opposite edges of the wound and stretching the skin. The wound is then wiped with gauze, the ferric subsulfate solution applied, and the tension maintained for approximately 15 seconds.2

Storage ⮝

Keep tightly closed and protect from light. DO NOT use if seal is broken. Store at room temperature 59 -86 F (15 -30 C).

Disposal ⮝

Opened containers with unused portions of product and applicator swabs containing residual product should be placed in a suitable, dry container for later disposal according to local hazardous waste practices. Waste containing AstrinGyn should not be subjected to any thermal process whether intended for destruction or recycling purposes.

References ⮝

• Armstrong RB, Nichols J. Pachance J. Punch biopsy wounds treated with Monsel s solution or a collagen matrix. A comparison of healing. Arch. Dermatol 1986;122:546-549.
  
• Baden HP, Rapid hemostasis with Monsel s solution (letter). Arch Dermatol 1984; 120:708.
  
• Demis DJ, Clinical dermatology, Hagerstown MD: Harper & Row, 1986; pp. 11-4:1-11-4:5.
  
• Camisa C, Roberts W. Monsel solution tattooing (letter). J Am Acad Dermatol 1983;8:753-754.
  
• Amazon K, Robinson MJ, Rywlin AM. Ferrugination caused by Monsel s solution. Clinical observations and experimentation. Am J Dermatopathol 1980;2:197-205.
  
• Davis JR, Steinbronn KK, Graham AR, Dawson BV. Effects of Monsel s solution in uterine cervix, AM J Clin Pathol 1984;82:332-335.
  
• Horn MS, Circeo RB, Hassan C. Radiographic artifacts produced by silver nitrate and Monsel s solution (letter). J Am Acad Dernatol 1983;8:560-562.
  
• Olmstead PM, Lund HZ, Leonard DD. Monsel s solution: a histologic nuisance. J Am Acad Dermatol 1980;3:492-498.
  
• Wood C, Severin GL. Unusual histiocytic reaction to Monsel s solution. Am J Dermatopathol 1980;2:261-264.

Principal Display Panel  ⮝

AstrinGYN (ferric subsulfate)
NDC 59365-6065-0

LEEP REDIKIT mepivacaine hydrochloride, lidocaine hydrochloride, epinephrine bitartrate, iodine, potassium iodide, ferric subsulfate kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59365-6061

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59365-6061-1 1 in 1 PACKAGE; Type 0: Not a Combination Product 05/31/2015 2 NDC:59365-6061-2 5 in 1 PACKAGE 05/31/2015 2 NDC:59365-6061-1 1 in 1 PACKAGE; Type 0: Not a Combination Product

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, MULTI-DOSE 10 mL Part 2 1 VIAL, SINGLE-USE 8 mL Part 3 1 VIAL, SINGLE-USE 8 g

Part 1 of 3 XYLOCAINE lidocaine hydrochloride anhydrous and epinephrine bitartrate injection, solution

Product Information Route of Administration INFILTRATION, PERINEURAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL EPINEPHRINE BITARTRATE (UNII: 30Q7KI53AK) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE 0.01 mg in 1 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.2 mg in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 7 mg in 1 mL SODIUM METABISULFITE (UNII: 4VON5FNS3C) 0.5 mg in 1 mL METHYLPARABEN (UNII: A2I8C7HI9T) 1 mg in 1 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA006488

Part 2 of 3 LUGOLS STRONG IODINE iodine and potassium iodide solution

Product Information Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 0.05 g in 1 mL POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 0.100 g in 1 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER

Part 3 of 3 ASTRINGYN ferric subsulfate solution

Product Information Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION 259 mg in 1 g

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) POVIDONE (UNII: FZ989GH94E) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 05/31/2015

Labeler - CooperSurgical, Inc. (801895244)

Revised: 8/2016 Document Id: 01b6b213-a18c-4379-b6d7-58304c0cd1a7 34391-3 Set id: 37f4ce91-7546-4502-8298-1e1210e99461 Version: 3 Effective Time: 20160816 CooperSurgical, Inc.