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CICLOPIROX OLAMINE cream


  1. No Title 1572555381
  2. Ciclopirox Olamine Cream Usp, 0.77%
  3. Description
  4. Clinical Pharmacology
  5. Indications And Usage
  6. Contraindications
  7. Warnings
  8. Precautions
  9. Adverse Reactions
  10. Dosage And Administration
  11. How Supplied
  12. Principal Display Panel
  13. Ciclopirox Olamine 15g Cream
  14. No Title 1572452480
  15. Description
  16. Clinical Pharmacology
  17. Indications And Usage
  18. Contraindications
  19. Warnings
  20. Precautions
  21. Adverse Reactions
  22. Dosage And Administration
  23. How Supplied
  24. Principal Display Panel - 30 G Carton
  25. Principle Display Panel

No Title 1572555381 

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

Revised: July 2013

PK-4597-1 226

Ciclopirox Olamine Cream Usp, 0.77%  

FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.

Description  

Ciclopirox olamine cream USP, 0.77% is for topical use. Each gram of ciclopirox olamine cream USP contains 7.70 mg of ciclopirox (as ciclopirox olamine USP) in a water miscible vanishing cream base consisting of purified water USP, cetyl alcohol NF, light mineral oil NF, octyldodecanol NF, stearyl alcohol NF, polysorbate 60 NF, myristyl alcohol NF, sorbitan monostearate NF, lactic acid USP, and benzyl alcohol NF (1%) as preservative.

Ciclopirox olamine cream USP contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine USP). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2 -aminoethanol salt.

The CAS Registry Number is 41621-49-2. The chemical structure is:

Chemical Structure of Ciclopirox

Clinical Pharmacology  

Ciclopirox is a broad-spectrum, antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and Malassezia furfur. Ciclopirox exhibits fungicidal activity in vitro against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida albicans.

Pharmacokinetic studies in men with tagged ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm2 on the back followed by occlusion for 6 hours. The biological half-life was 1.7 hours and excretion occurred via the kidney. Two days after application only 0.01% of the dose applied could be found in the urine. Fecal excretion was negligible.

Penetration studies in human cadaverous skin from the back, with ciclopirox olamine cream with tagged ciclopirox showed the presence of 0.8 to 1.6% of the dose in the stratum corneum 1.5 to 6 hours after application. The levels in the dermis were still 10 to 15 times above the minimum inhibitory concentration.

Autoradiographic studies with human cadaverous skin showed that ciclopirox penetrated into the hair and through the epidermis and hair follicles into the sebaceous glands and dermis, while a portion of the drug remains in the stratum corneum.

Draize Human Sensitization Assay, 21-Day Cumulative Irritancy study, Phototoxicity study, and Photo-Draize study conducted in a total of 142 healthy male subjects showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity, and no photo-contact sensitization due to ciclopirox olamine cream.

Indications And Usage  

Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) vesicolor due to Malassezia furfur.

Contraindications  

Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings  

Ciclopirox olamine cream is not for ophthalmic use.
Keep out of the reach of children.

Precautions  

If a reaction suggesting sensitivity or chemical irritation should occur with the use of ciclopirox olamine cream, treatment should be discontinued and appropriate therapy instituted.

Information for Patients

The patient should be told to:

  1. Use the medication for the full treatment time even though symptoms may have improved and notify the physician if there is no improvement after four weeks.
  2. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing) indicative of possible sensitization.
  3. Avoid the use of occlusive wrappings or dressings.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A carcinogenicity study in female mice dosed cutaneously twice per week for 50 weeks followed by a 6-month drug-free observation period prior to necropsy revealed no evidence of tumors at the application site.

The following in vitro and in vivo genotoxicity tests have been conducted with ciclopirox olamine: studies to evaluate gene mutation in the Ames Salmonella/Mammalian Microsome Assay (negative) and Yeast Saccharomyces Cerevisiae Assay (negative) and studies to evaluate chromosome aberrations in vivo in the Mouse Dominant Lethal Assay and in the Mouse Micronucleus Assay at 500 mg/kg (negative).

The following battery of in vitro genotoxicity tests were conducted with ciclopirox: a chromosome aberration assay in V79 Chinese Hamster Cells, with and without metabolic activation (positive); a gene mutation assay in the HGPRT test with V79 Chinese Hamster Cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA Synthesis Assay in A549 Human Cells (negative). An in vitro Cell Transformation Assay in BALB/C3T3 Cells was negative for cell transformation. In an in vivo Chinese Hamster Bone Marrow Cytogenetic Assay, ciclopirox was negative for chromosome aberrations at 5,000 mg/kg.

Pregnancy Category B

Reproduction studies have been performed in the mouse, rat, rabbit, and monkey (via various routes of administration) at doses 10 times or more the topical human dose and have revealed no significant evidence of impaired fertility or harm to the fetus due to ciclopirox. There are, however, no adequate or well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ciclopirox olamine cream is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 10 years have not been established.

Adverse Reactions  

In all controlled clinical studies with 514 patients using ciclopirox olamine cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox olamine cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.

Dosage And Administration  

Gently massage ciclopirox olamine cream into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with ciclopirox olamine cream, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

How Supplied  

Ciclopirox olamine cream USP, 0.77% is supplied in 15 gram (NDC 68462-297-17), 30 gram (NDC 68462-297-35) and 90 gram (NDC 68462-297-92) tubes.

Store at 20-25oC (68-77oF) [see USP Controlled Room Temperature].

Manufactured by:

Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured for:

Glenmark Logo

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115
www.glenmarkgenerics.com

February 2011

Principal Display Panel 


NDC 68258-3996-03

NDC 68258-3996-03

CICLOPIROX OLAMINE
ciclopirox olamine cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68258-3996(NDC:68462-297)
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CICLOPIROX OLAMINE (UNII: 50MD4SB4AP) (CICLOPIROX - UNII:19W019ZDRJ) CICLOPIROX 7.7 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
OCTYLDODECANOL (UNII: 461N1O614Y)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
LACTIC ACID (UNII: 33X04XA5AT)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68258-3996-3 30 g in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090273 11/13/2009
Labeler - Dispensing Solutions, Inc. (066070785)
Registrant - PSS World Medical, Inc. (101822682)
Establishment
Name Address ID/FEI Business Operations
Dispensing Solutions, Inc. 066070785 relabel(68258-3996) , repack(68258-3996)

Revised: 10/2012 Dispensing Solutions, Inc.

Ciclopirox Olamine 15g Cream 

DESCRIPTION

Ciclopirox olamine cream, USP is for topical use.

Each gram of ciclopirox olamine cream, USP contains 7.70 mg of ciclopirox (as Ciclopirox Olamine) in a water miscible vanishing cream base consisting of Purified Water USP, Octyldodecanol NF, Light Mineral Oil NF, Stearyl Alcohol NF, Cetyl Alcohol NF, Polysorbate 60 NF, Myristyl Alcohol NF, Sorbitan Monostearate NF, Lactic Acid USP, and Benzyl Alcohol NF (1%) as preservative.

Ciclopirox olamine cream, USP contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt.

The CAS Registry Number is 41621-49-2. The chemical structure is

Ciclopirox olamine cream, USP has a pH of 7.


CLINICAL PHARMACOLOGY
Ciclopirox is a broad-spectrum, antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and Malassezia furfur. Ciclopirox exhibits fungicidal activity in vitro against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermorphyton floccosum, Microsporum canis, and Candida albicans.

Pharmacokinetic studies in men with tagged ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm2 on the back followed by occlusion for 6 hours. The biological half-life was 1.7 hours and excretion occurred via the kidney. Two days after application only 0.01% of the dose applied could be found in the urine. Fecal excretion was negligible.


Penetration studies in human cadaverous skin from the back, with ciclopirox olamine cream, USP with tagged ciclopirox showed the presence of 0.8 to 1.6% of the dose in the stratum corneum 1.5 to 6 hours after application. The levels in the dermis were still 10 to 15 times above the minimum inhibitory concentrations.


Autoradiographic studies with human cadaverous skin showed that ciclopirox penetrates into the hair and through the epidermis and hair follicles into the sebaceous glands and dermis, while a portion of the drug remains in the stratum corneum.

Draize Human Sensitization Assay, 21-Day Cumulative Irritancy study, Phototoxicity study, and Photo-Draize study conducted in a total of 142 healthy subjects showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity, and no photo-contact sensitization due to ciclopirox olamine cream, USP.

INDICATIONS AND USAGE

Ciclopirox olamine cream, USP is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.

CONTRAINDICATIONS

Ciclopirox olamine cream, USP is contraindicated in individuals who have shown hypersensitivity to any of its components.

WARNINGS

Ciclopirox olamine cream, USP is not for ophthalmic use.

Keep out of reach of children.

PRECAUTIONS

If a reaction suggesting sensitivity or chemical irritation should occur with the use of ciclopirox olamine cream, USP, treatment should be discontinued and appropriate therapy instituted.

ADVERSE REACTIONS

In all controlled clinical studies with 514 patients using ciclopirox olamine cream, USP and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox olamine cream, USP and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.

DOSAGE AND ADMINISTRATION

Gently massage ciclopirox olamine cream, USP into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with ciclopirox olamine cream, USP the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

HOW SUPPLIED

Ciclopirox olamine cream, USP is supplied in 15 gram, 30 gram, and 90 gram tubes.

Information for Patients

The patient should be told to:

  1. Use the medication for the full treatment time even though symptoms may have improved and notify the physician if there is no improvement after four weeks.
  2. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing) indicative of possible sensitization.
  3. Avoid the use of occlusive wrappings or dressings.

Image of labelImage of label

CICLOPIROX OLAMINE
ciclopirox olamine cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49999-646(NDC:45802-138)
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CICLOPIROX OLAMINE (UNII: 50MD4SB4AP) (CICLOPIROX - UNII:19W019ZDRJ) CICLOPIROX OLAMINE 7.7 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
OCTYLDODECANOL (UNII: 461N1O614Y)
MINERAL OIL (UNII: T5L8T28FGP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
LACTIC ACID (UNII: 33X04XA5AT)
BENZYL ALCOHOL (UNII: LKG8494WBH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49999-646-15 15 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077364 11/03/2010
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
Name Address ID/FEI Business Operations
Lake Erie Medical DBA Quality Care Products LLC 831276758 relabel
Establishment
Name Address ID/FEI Business Operations
L.Perrigo Company 006013346 manufacture

Revised: 11/2010 Lake Erie Medical DBA Quality Care Products LLC

No Title 1572452480 

Rx Only

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

Description 

Ciclopirox Olamine Cream USP, 0.77% is for topical use.

Each gram of ciclopirox olamine cream USP contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible vanishing cream base consisting of cetyl alcohol, cocamide DEA, lactic acid, mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, stearyl alcohol, and benzyl alcohol (1%) as preservative.

Ciclopirox olamine cream contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H)-pyridone, 2-aminoethanol salt.

The CAS Registry Number is 41621-49-2. The chemical structure is:

Chemical Structure

Clinical Pharmacology 

Mechanism of Action

Ciclopirox is a hydroxypyridone antifungal agent that acts by chelation of polyvalent cations (Fe 3+ or Al 3+), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell.

Pharmacokinetics

Pharmacokinetic studies in men with tagged ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm 2 on the back followed by occlusion for 6 hours. The biological half-life was 1.7 hours and excretion occurred via the kidney. Two days after application only 0.01% of the dose applied could be found in the urine. Fecal excretion was negligible.

Penetration studies in human cadaverous skin from the back, with ciclopirox with tagged ciclopirox showed the presence of 0.8 to 1.6% of the dose in the stratum corneum 1.5 to 6 hours after application. The levels in the dermis were still 10 to 15 times above the minimum inhibitory concentrations.

Autoradiographic studies with human cadaverous skin showed that ciclopirox penetrates into the hair and through the epidermis and hair follicles into the sebaceous glands and dermis, while a portion of the drug remains in the stratum corneum.

Draize Human Sensitization Assay, 21-Day Cumulative Irritancy study, Phototoxicity study, and Photo-Draize study conducted in a total of 142 healthy male subjects showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity, and no photo-contact sensitization due to Ciclopirox Olamine Cream USP, 0.77%.

Indications And Usage 

Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.

Contraindications 

Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings 

Ciclopirox olamine cream is not for ophthalmic use.

Keep out of reach of children.

Precautions 

If a reaction suggesting sensitivity or chemical irritation should occur with the use of ciclopirox olamine cream, treatment should be discontinued and appropriate therapy instituted.

Information for Patients

The patient should be told to:

  1. Use the medication for the full treatment time even though symptoms may have improved and notify the physician if there is no improvement after four weeks.
  2. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing) indicative of possible sensitization.
  3. Avoid the use of occlusive wrappings or dressings.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A 104-week dermal carcinogenicity study in mice was conducted with ciclopirox cream applied at doses up to 1.93% (100 mg/kg/day or 300 mg/m 2/day). No increase in drug related neoplasms was noted when compared to control.

The following in vitro genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in the Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells, with and without metabolic activation (positive); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells in the presence of supplemental Fe 3+, with and without metabolic activation (negative); gene mutation assays in the HGPRT-test with V79 Chinese hamster lung fibroblast cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA synthesis assay in A549 human cells) (negative). An in vitro cell transformation assay in BALB/c 3T3 cells was negative for cell transformation. In an in vivo Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at a dosage of 5000 mg/kg body weight.

A combined oral fertility and embryofetal developmental study was conducted in rats with ciclopirox olamine. No effect on fertility or reproductive performance was noted at the highest dose tested of 3.85 mg/kg/day ciclopirox (approximately 1.2 times the maximum recommended human dose based on body surface area comparisons).

Pregnancy

Teratogenic Effects

Pregnancy Category B

There are no adequate or well-controlled studies in pregnant women. Therefore, ciclopirox olamine cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral embryofetal developmental studies were conducted in mice, rats, rabbits and monkeys. Ciclopirox or ciclopirox olamine was orally administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 77, 125, 80 and 38.5 mg/kg/day ciclopirox in mice, rats, rabbits and monkeys, respectively (approximately 11, 37, 51 and 24 times the maximum recommended human dose based on body surface area comparisons, respectively).

Dermal embryofetal developmental studies were conducted in rats and rabbits with ciclopirox olamine dissolved in PEG 400. Ciclopirox olamine was topically administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 92 mg/kg/day and 77 mg/kg/day ciclopirox in rats and rabbits, respectively (approximately 27 and 49 times the maximum recommended human dose based on body surface area comparisons, respectively).

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ciclopirox olamine cream is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 10 years have not been established.

Adverse Reactions 

In all controlled clinical studies with 514 patients using ciclopirox olamine cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.

Dosage And Administration 

Gently massage ciclopirox olamine cream into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with ciclopirox olamine cream, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

How Supplied 

Ciclopirox Olamine Cream USP, 0.77% is supplied in Box of 30 g (NDC 68071-4162-3)

Store at 20 -25 C (68 -77 F) [see USP Controlled Room Temperature].

Principal Display Panel - 30 G Carton 

pdp

CICLOPIROX OLAMINE
ciclopirox olamine cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-4162(NDC:51672-1318)
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CICLOPIROX OLAMINE (UNII: 50MD4SB4AP) (CICLOPIROX - UNII:19W019ZDRJ) CICLOPIROX 7.7 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
LACTIC ACID (UNII: 33X04XA5AT)
MINERAL OIL (UNII: T5L8T28FGP)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68071-4162-3 30 g in 1 BOX; Type 0: Not a Combination Product 11/22/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076790 04/12/2005
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Business Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-4162)

Revised: 4/2019 NuCare Pharmaceuticals,Inc.

Principle Display Panel 

NDC 68462-297-35
Ciclopirox Olamine Cream USP, 0.77%
For dermatologic use only. Not for use in eyes.

Carton30g
CICLOPIROX OLAMINE
ciclopirox olamine cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-297
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CICLOPIROX OLAMINE (UNII: 50MD4SB4AP) (CICLOPIROX - UNII:19W019ZDRJ) CICLOPIROX 7.7 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
OCTYLDODECANOL (UNII: 461N1O614Y)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68462-297-17 15 g in 1 CARTON; Type 0: Not a Combination Product 11/13/2009
2 NDC:68462-297-35 30 g in 1 CARTON; Type 0: Not a Combination Product 11/13/2009
3 NDC:68462-297-92 90 g in 1 CARTON; Type 0: Not a Combination Product 11/13/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090273 11/13/2009
Labeler - Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 677318665 ANALYSIS(68462-297) , MANUFACTURE(68462-297)
Establishment
Name Address ID/FEI Business Operations
Olon SpA 437723684 ANALYSIS(68462-297)

Revised: 8/2019 Glenmark Pharmaceuticals Inc., USA



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