Clobex (Page 4 of 4)

PACKAGE LABEL

4-fl-oz-carton-image
(click image for full-size original)

Rx Only

NDC 0299-3847-04

Clobex® (clobetasol propionate)

SHAMPOO

0.05%

4 FL OZ

(118 mL)

GALDERMA

For External Use Only.

Not for Ophthalmic Use.

Usual dosage:

Apply a thin film to affected areas of the scalp once daily; apply on dry scalp and leave in place for 15 minutes before lathering and rinsing. Do not apply CLOBEX® (clobetasol propionate) Shampoo, 0.05% to the face, underarms or groin, and avoid contact with eyes and lips. Do not use for longer than 4 weeks. See package insert for complete prescribing information.
See carton closure for lot number and expiration date.

Each mL contains: Active ingredient: clobetasol propionate, 0.05%.

Excipients: alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate.

Storage: Keep tightly closed. Store at controlled room temperature 68° to 77°F (20°- 25°C) with excursions permitted between 59° to 86°F (15°- 30°C).

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, Texas 76177 USA
Made in Canada
All trademarks are the property of their respective owners.P51351-3

CLOBEX clobetasol propionate shampoo
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-3847
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Clobetasol propionate (Clobetasol) Clobetasol propionate 0.05 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
alcohol
citric acid monohydrate
COCO-BETAINE
POLYQUATERNIUM-10 (400 CPS AT 2%)
water
sodium citrate
SODIUM LAURETH SULFATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-3847-04 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (0299-3847-04)
2 NDC:0299-3847-00 1 BOTTLE in 1 BLISTER PACK contains a BOTTLE (0299-3847-05)
2 NDC:0299-3847-05 15 mL in 1 BOTTLE This package is contained within the BLISTER PACK (0299-3847-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021644 03/01/2004
Labeler — Galderma Laboratories, L.P. (047350186)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd. 832224526 manufacture (0299-3847)
Establishment
Name Address ID/FEI Operations
G Production, Inc. 251676961 manufacture (0299-3847)

Revised: 08/2021 Galderma Laboratories, L.P.

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