Label: ANTI-FUNGAL- miconazole nitrate cream
- NDC Code(s): 52000-021-40, 52000-021-41
- Packager: Universal Distribution Center LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 21, 2024
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- 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:52000-021-41 1 in 1 BOX 02/14/2022 1 NDC:52000-021-40 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 Drug M005 04/15/2015 Labeler - Universal Distribution Center LLC (019180459) Registrant - Savvy Care And Cosmetics Pvt. Ltd. (915039748) Establishment Name Address ID/FEI Business Operations Savvy Care And Cosmetics Pvt. Ltd. 915039748 manufacture(52000-021)