Label: FLUOCINONIDE cream
- NDC Code(s): 70771-1393-2, 70771-1393-3, 70771-1393-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 5, 2022
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INGREDIENTS AND APPEARANCE
FLUOCINONIDE
fluocinonide creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1393 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUOCINONIDE (UNII: 2W4A77YPAN) (FLUOCINONIDE - UNII:2W4A77YPAN) FLUOCINONIDE 1 mg in 1 g Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) DIISOPROPANOLAMINE (UNII: 0W44HYL8T5) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) 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:70771-1393-2 30 g in 1 TUBE; Type 0: Not a Combination Product 04/30/2020 2 NDC:70771-1393-3 60 g in 1 TUBE; Type 0: Not a Combination Product 04/30/2020 3 NDC:70771-1393-5 120 g in 1 TUBE; Type 0: Not a Combination Product 04/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208989 04/30/2020 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1393) , MANUFACTURE(70771-1393)
