Label: FIFTHPULSE MICONAZOLE NITRATE CREAM 1OZ- miconazole nitrate cream
- NDC Code(s): 69571-016-01
- Packager: Front Pharmaceutical PLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 18, 2025
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INGREDIENTS AND APPEARANCE
FIFTHPULSE MICONAZOLE NITRATE CREAM 1OZ
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69571-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHYL SULFOXIDE (UNII: YOW8V9698H) ALCOHOL (UNII: 3K9958V90M) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) STEARIC ACID (UNII: 4ELV7Z65AP) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) Product Characteristics Color Score Shape Size 105mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69571-016-01 28.4 g in 1 TUBE; Type 0: Not a Combination Product 07/19/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 07/19/2025 Labeler - Front Pharmaceutical PLC (530897792) Registrant - Front Pharmaceutical PLC (530897792) Establishment Name Address ID/FEI Business Operations Front Pharmaceutical PLC 530897792 manufacture(69571-016)
