Label: ANTIFUNGAL- miconazole nitrate cream
- NDC Code(s): 63187-885-15
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0472-0735
- 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 April 1, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
- DO NOT USE
- When using this product
- Stop use and ask a doctor if
- KEEP OUT OF REACH OF CHILDREN
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Directions
- •
- wash the affected area and dry thoroughly
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- apply a thin layer of the product 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 daily
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- 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
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- this product is not effective on the scalp or nails
- Other information
- Inactive ingredients
- Questions?
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INGREDIENTS AND APPEARANCE
ANTIFUNGAL
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-885(NDC:0472-0735) 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 BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) MINERAL OIL (UNII: T5L8T28FGP) PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-885-15 1 in 1 CARTON 09/01/2017 1 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 05/01/2007 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(63187-885)
