Clotrimazole and Betamethasone Dipropionate (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Actavis

NDC 0472-0379 -15

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base)

Rx Only

FOR TOPICAL USE ONLY. NOT FOR OPTHALMIC, ORAL, OR INTRAVAGINAL USE.
NOT RECOMMENDED FOR PATIENTS UNDER THE AGE OF 17 YEARS AND NOT
RECOMMENDED FOR DIAPER DERMATITIS.

15 g(0.53 oz)

1
(click image for full-size original)

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
clotrimazole and betamethasone dipropionate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-0379
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 10 mg in 1 g
BETAMETHASONE DIPROPIONATE (BETAMETHASONE) BETAMETHASONE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETEARETH-30
CETYL ALCOHOL
MINERAL OIL
PROPYLENE GLYCOL
WATER
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
STEARYL ALCOHOL
PETROLATUM
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0472-0379-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (0472-0379-15)
2 NDC:0472-0379-45 1 TUBE in 1 CARTON contains a TUBE
2 45 g in 1 TUBE This package is contained within the CARTON (0472-0379-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076002 12/16/2003
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 11/2019 Actavis Pharma, Inc.

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.