Label: CLOBETASOL PROPIONATE ointment
-
Contains inactivated NDC Code(s)
NDC Code(s): 71589-002-15, 71589-002-30, 71589-002-45, 71589-002-60 - Packager: Aleor Dermaceuticals Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 1, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CLOBETASOL PROPIONATE
clobetasol propionate ointmentProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71589-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H) CLOBETASOL PROPIONATE 0.5 mg in 1 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71589-002-15 1 in 1 CARTON 03/12/2019 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:71589-002-30 1 in 1 CARTON 03/12/2019 2 30 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:71589-002-45 1 in 1 CARTON 03/12/2019 3 45 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:71589-002-60 1 in 1 CARTON 03/12/2019 4 60 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211800 03/12/2019 Labeler - Aleor Dermaceuticals Limited (871411532) Registrant - Aleor Dermaceuticals Limited (871411532) Establishment Name Address ID/FEI Business Operations Encube Ethicals Pvt. Ltd. 725076298 MANUFACTURE(71589-002)
