Label: ANTIFUNGAL CREAM- miconazole nitrate cream
- NDC Code(s): 21922-095-06
- Packager: Encube Ethicals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 4, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
■ clean the affected area and dry thoroughly
■ apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
■ supervise children in the use of this product
■ for athlete's foot: pay special attention to the spaces between the toes; wear well-filling, ventilated shoes, and change shoes and socks at least once daily
■ for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
■ if condition lasts longer, contact a doctor
■ this product is not effective on the scalp or nails
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OTHER INFORMATION
■ do not use if foil seal on tube opening is broken or missing
■ to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
■ store at room temperature 15°C to 30°C (59°F to 86°F)
■ before using any medication, read all label directions. Keep carton, it contains important information.
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ANTIFUNGAL CREAM
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21922-095 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) MINERAL OIL (UNII: T5L8T28FGP) APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ) PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21922-095-06 1 in 1 CARTON 03/06/2025 1 42.5 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 OTC Monograph Drug M005 03/06/2025 Labeler - Encube Ethicals, Inc. (116982244) Registrant - Encube Ethicals Private Limited (915834105) Establishment Name Address ID/FEI Business Operations Encube Ethicals Private Limited 725076298 analysis(21922-095) , label(21922-095) , manufacture(21922-095) , pack(21922-095)

