Label: CLOBETASOL PROPIONATE cream
- NDC Code(s): 70771-1442-1, 70771-1442-2, 70771-1442-3, 70771-1442-4
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 13, 2022
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INGREDIENTS AND APPEARANCE
CLOBETASOL PROPIONATE
clobetasol propionate creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1442 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) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYSORBATE 60 (UNII: CAL22UVI4M) LANOLIN OIL (UNII: OVV5IIJ58F) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) GLYCOL STEARATE (UNII: 0324G66D0E) PEG-8 STEARATE (UNII: 2P9L47VI5E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1442-1 1 in 1 CARTON 01/09/2019 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70771-1442-2 1 in 1 CARTON 01/09/2019 2 30 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:70771-1442-4 1 in 1 CARTON 01/09/2019 3 45 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:70771-1442-3 1 in 1 CARTON 01/09/2019 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 ANDA211074 01/09/2019 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (650650802) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1442) , MANUFACTURE(70771-1442)