NDC Code(s) : 71589-007-04
Packager : Aleor Dermaceuticals Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SHAMPOO
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71589-007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOBETASOL PROPIONATE(UNII: 779619577M)
(CLOBETASOL - UNII:ADN79D536H) 		CLOBETASOL PROPIONATE0.05 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
COCO-BETAINE(UNII: 03DH2IZ3FY)
POLYQUATERNIUM-10 (400 CPS AT 2%)(UNII: HB1401PQFS)
WATER(UNII: 059QF0KO0R)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SODIUM LAURETH SULFATE(UNII: BPV390UAP0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71589-007-041 in 1 CARTON 06/01/2020
1118 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213290 06/01/2020

LABELER - Aleor Dermaceuticals Limited(871411532)

REGISTRANT - Aleor Dermaceuticals Limited(871411532)

Establishment
Name Address ID/FEI Business Operations
Aleor Dermaceuticals Limited 871411532 MANUFACTURE(71589-007), ANALYSIS(71589-007)

PRINCIPAL DISPLAY PANEL

Rx Only

NDC 71589-007-04

Clobetasol Propionate Shampoo, 0.05%

4 FL OZ

(118 mL)

ALEOR

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 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 top of the carton for lot number and expiration date.

Each mL Contains: Active Ingredient: Clobetasol propionate USP, 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° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C).

Manufactured by:

Aleor Dermaceuticals Ltd.,

Karakhadi, Vadodara 391450, India.

Mfg. License No: G/25/2216

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