Acyclovir (Page 4 of 4)

PRINCIPAL DISPLAY PANEL – 5 g Tube Carton

NDC 0093-3630 -20
Acyclovir Cream
5%

Each gram contains: 50 mg (equivalent to 5% w/w) acyclovir, cetostearyl alcohol, mineral oil,
poloxamer 407, propylene glycol, sodium lauryl sulfate, water, and white petrolatum.

Net Wt. 5 g

USE ONLY FOR COLD SORES.
FOR CUTANEOUS USE ONLY.

Rx only

TEVA

carton
(click image for full-size original)
ACYCLOVIR acyclovir cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3630
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
acyclovir (acyclovir) acyclovir 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Cetostearyl alcohol
Mineral oil
Poloxamer 407
Sodium lauryl sulfate
Water
Petrolatum
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-3630-20 1 TUBE in 1 CARTON contains a TUBE
1 5 g in 1 TUBE This package is contained within the CARTON (0093-3630-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021478 08/29/2019
Labeler — Teva Pharmaceuticals, Inc. (001627975)
Establishment
Name Address ID/FEI Operations
Bausch Health Companies Inc. 245141858 MANUFACTURE (0093-3630), PACK (0093-3630)

Revised: 02/2021 Teva Pharmaceuticals, Inc.

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