Label: ANTI-FUNGAL- miconazole nitrate cream
- NDC Code(s): 52000-021-36, 52000-021-37
- Packager: Universal Distribution Center LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 21, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
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wash affected area and dry thoroughly
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Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
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supervise children in the use of this product
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for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day
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for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
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if conditions persist longer, ask a doctor
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this product is not effective on the scalp or nails.
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- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI-FUNGAL
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) MINERAL OIL (UNII: T5L8T28FGP) PEG-5 OLEATE (UNII: 0240V77G50) PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-021-37 1 in 1 BOX 02/14/2022 1 NDC:52000-021-36 14 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 final part333C 04/15/2015 Labeler - Universal Distribution Center LLC (019180459) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(52000-021)
