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EPINASTINE- epinastine hydrochloride solution/ drops


  1. Patient Information
  2. Principal Display Panel Text For Container Label:
  3. Principal Display Panel Text For Carton Label:
  4. Revised: 5/2017document Id:

Patient Information 

17.1 Sterility of Dropper Tip

Patients should be advised not to touch dropper tip to any surface, as this may contaminate the contents (seeWARNINGS AND PRECAUTIONS, 5.1).

17.2 Concomitant Use of Contact Lenses

Patients should be advised not to wear a contact lens if their eye is red. Patients should be advised that Epinastine Hydrochloride Ophthalmic Solution should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of Epinastine Hydrochloride Ophthalmic Solution. The preservative in Epinastine Hydrochloride Ophthalmic Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Epinastine Hydrochloride Ophthalmic Solution.

17.3 Topical Ophthalmic Use Only

For topical ophthalmic administration only.

Rx only



AKORN Logo

Manufactured by:Akorn, Inc.
Lake Forest, IL 60045
EP00N Rev. 05/17

Principal Display Panel Text For Container Label: 

NDC 17478-911-05
Epinastine HCl
Ophthalmic Solution
0.05%
FOR USE IN THE
EYES ONLY Eye logo
containerlabel

Principal Display Panel Text For Carton Label: 

NDC 17478-911-05
Epinastine HCl
Ophthalmic
Solution
0.05%
FOR USE IN THE EYES ONLY
Eye logo
5 mL
Rx only Akorn logo
carton

EPINASTINE
epinastine hydrochloride solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-911
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPINASTINE HYDROCHLORIDE(UNII: GFM415S5XL) (EPINASTINE - UNII:Q13WX941EF)EPINASTINE HYDROCHLORIDE0.5 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM(UNII: 7FLD91C86K)
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC(UNII: 3980JIH2SW)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-911-055 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20405505/05/2017
Labeler -Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc.603980319ANALYSIS(17478-911) , RELABEL(17478-911) , REPACK(17478-911) , STERILIZE(17478-911) , LABEL(17478-911) , MANUFACTURE(17478-911) , PACK(17478-911)

Revised: 5/2017document Id: 

0239697b-0d90-43f7-92be-4af4f7273c95Set id: 4e1fcdcd-34f9-4513-969d-18354e12c735Version: 3Effective Time: 20170501Akorn, Inc.



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