NDC Code(s) : 71589-003-59, 71589-003-12
Packager : Aleor Dermaceuticals Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clobetasol Propionate Clobetasol Propionate SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71589-003
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 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
UNDECYLENIC ACID(UNII: K3D86KJ24N)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71589-003-591 in 1 CARTON 31/10/2019
159 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:71589-003-121 in 1 CARTON 31/10/2019
2125 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 ANDA211191 10/31/2019

LABELER - Aleor Dermaceuticals Limited(871411532)

REGISTRANT - Aleor Dermaceuticals Limited(871411532)

Establishment
Name Address ID/FEI Business Operations
Contract Pharmaceuticals Limited Canada 248761249 MANUFACTURE(71589-003)

Establishment
Name Address ID/FEI Business Operations
Aleor Dermaceuticals Limited 871411532 MANUFACTURE(71589-003), ANALYSIS(71589-003)

PRINCIPAL DISPLAY PANEL

Rx Only

NDC 71589-003-59

Clobetasol Propionate Spray, 0.05%

For topical use only

2 FL OZ

(59 mL)

Aleor Dermaceuticals Ltd.,

WARNING: FLAMMABLE AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION

Not for eye use.

Usual dosage: Apply twice daily, once in the morning and once at night.

Use only enough to cover the affected areas. Do not exceed 26 sprays per application or 52 sprays per day. Do not apply to face, underarms, or groin and avoid contact with eyes and lips. See package insert for complete prescribing information. See lot number and expiration date on the bottom of the carton.

TO THE PHARMACIST

  • Ensure the patient receives the Patient Information.
  • Replace cap with spray pump prior to dispensing .

Each gram contains: Active: clobetasol propionate (0.5 mg).

Inactive: alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.

Store at controlled room temperature 68° to 77°F (20° to 25°C); excursions permitted between 59° to 86°F (15° to 30°C).

Protect from freezing.

Do not refrigerate or store above 86°F (30°C).

Keep out of reach of children.

Manufactured for:

Aleor Dermaceuticals Ltd.,

Karakhadi, Vadodara 391450 India.

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