Label: TRETINOIN cream
- NDC Code(s): 70771-1873-2, 70771-1873-4
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 26, 2024
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INGREDIENTS AND APPEARANCE
TRETINOIN
tretinoin creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1873 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN 1 mg in 1 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) SORBIC ACID (UNII: X045WJ989B) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1873-2 1 in 1 CARTON 04/30/2024 1 20 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70771-1873-4 1 in 1 CARTON 04/30/2024 2 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 ANDA218561 04/30/2024 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1873) , MANUFACTURE(70771-1873)
