Label: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE gel
- NDC Code(s): 70771-1450-4
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 26, 2024
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INGREDIENTS AND APPEARANCE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
clindamycin phosphate and benzoyl peroxide gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1450 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN PHOSPHATE 10 mg in 1 g BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) DIMETHICONE (UNII: 92RU3N3Y1O) DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342) EDETATE SODIUM (UNII: MP1J8420LU) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLOXAMER 182 (UNII: JX0HIX6OAG) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1450-4 1 in 1 CARTON 03/07/2019 1 45 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 ANDA210794 03/07/2019 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1450) , MANUFACTURE(70771-1450)
