Label: CLOBETASOL PROPIONATE lotion
- NDC Code(s): 70771-1498-6, 70771-1498-7
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 14, 2024
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INGREDIENTS AND APPEARANCE
CLOBETASOL PROPIONATE
clobetasol propionate lotionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1498 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H) CLOBETASOL PROPIONATE 0.05 g in 100 mL Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) MINERAL OIL (UNII: T5L8T28FGP) PEG-6 ISOSTEARATE (UNII: 0E2639OTJY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1498-7 1 in 1 CARTON 04/30/2020 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:70771-1498-6 1 in 1 CARTON 04/30/2020 2 59 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 ANDA205249 04/30/2020 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1498) , MANUFACTURE(70771-1498)
