AK-PENTOLATE (Page 2 of 2)

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed.

KEEP OUT OF THE REACH OF CHILDREN.

Akorn
Lake Forest, IL 60045

CP00N

Revised 05/08

Repackaged by:

Rebel Distributors Corp.

Thousand Oaks, CA 91320

Principal Display Panel

AK-Pentolate 1%
(click image for full-size original)

AK-PENTOLATE
cyclopentolate hydrochloride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-883(NDC:17478-100)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cyclopentolate Hydrochloride (Cyclopentolate) Cyclopentolate Hydrochloride 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride 0.1 mg in 1 mL
Boric Acid
Edetate Disodium
Potassium Chloride
Sodium Carbonate
Hydrochloric Acid
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-883-15 15 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040164 01/13/1997
Labeler — Rebel Distributors Corp. (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp. 118802834 RELABEL, REPACK

Revised: 09/2010 Rebel Distributors Corp.

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