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ACULAR- ketorolac tromethamine solution/ drops


  1. Patient Information
  2. Revised: 6/2012document Id:

Patient Information 

17.1 Slow or Delayed Healing

Patients should be informed of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs).

17.2 Avoiding Contamination of the Product

Patients should be instructed to avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Also, to avoid the potential for cross-contamination, the patient should be advised to use one bottle for each eye following bilateral ocular surgery. The use of the same bottle of topical eye drops for both eyes following bilateral ocular surgery is not recommended.

17.3 Contact Lens Wear

Patients should be advised thatACULARsolution should not be administered while wearing contact lenses.

17.4 Intercurrent Ocular Conditions

Patients should be advised that if they develop an intercurrent ocular condition (e.g., trauma or infection) or have ocular surgery, they should immediately seek their physician's advice concerning the continued use ofACULAR.

17.5 Concomitant Topical Ocular Therapy

Patients should be advised that if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart.


2012 Allergan, Inc., Irvine, CA 92612, U.S.A.

ACULARis manufactured and distributed by Allergan, Inc. under license from its developer, Roche Palo Alto LLC, Palo Alto, CA, U.S.A.

marks owned by Allergan, Inc.

Made in the U.S.A.

Allergan Logo

72379US10


ALLERGAN

NDC 0023-2181-05

ACULAR

(ketorolac

tromethamine

ophthalmic

solution)

0.5%

sterileRx only

5 mL

Carton
ACULAR
ketorolac tromethamine solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0023-2181
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketorolac Tromethamine(UNII: 4EVE5946BQ) (Ketorolac - UNII:YZI5105V0L)Ketorolac Tromethamine5 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride(UNII: F5UM2KM3W7)
edetate disodium(UNII: 7FLD91C86K)
octoxynol-40(UNII: 9T1C662FKS)
water(UNII: 059QF0KO0R)
sodium chloride(UNII: 451W47IQ8X)
hydrochloric acid(UNII: QTT17582CB)
sodium hydroxide(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0023-2181-051 in 1 CARTON12/01/1992
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01970012/01/1992
Labeler -Allergan, Inc. (144796497)
Establishment
NameAddressID/FEIBusiness Operations
Allergan Sales, LLC362898611MANUFACTURE(0023-2181)

Revised: 6/2012document Id: 

2df33f5e-153b-43fe-b56f-300599573549Set id: c94644d3-7b64-4f3d-a0c7-12c77466a0fcVersion: 7Effective Time: 20120618Allergan, Inc.



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