Latisse (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

LatisseĀ®
(bimatoprost ophthalmic
solution) 0.03%
3 mL
Rx only
Sterile

image of package labelimage of package label
LATISSE bimatoprost solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6053(NDC:0023-3616)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BIMATOPROST (BIMATOPROST) BIMATOPROST 0.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC
CITRIC ACID MONOHYDRATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6053-0 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 3 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (54868-6053-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022369 07/24/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 10/2009 Physicians Total Care, Inc.

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