Label: ANTIFUNGAL- miconazole nitrate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68345-817-25 - Packager: PSS World Medical, Inc.
- Category: HUMAN OTC DRUG LABEL
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 September 27, 2012
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
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Directions
Directions
- clean the affected area and dry thoroughly
- apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician
- supervise children in the use of this product
Athlete's Foot
- pay special attention to the spaces between toes
- wear well-fitting, ventilated shoes and change shoes and socks at least once daily
Athlete's Foot and Ringworm
- use daily for 4 weeks
Jock Itch
- use daily for 2 weeks
This product is not effective on scalp or nails.
- Inactive Ingredients
- Questions
- Storage
- Package Label
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INGREDIENTS AND APPEARANCE
ANTIFUNGAL
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68345-817 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PETROLATUM (UNII: 4T6H12BN9U) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68345-817-25 142 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 09/05/2012 Labeler - PSS World Medical, Inc. (101822682) Registrant - PSS World Medical, Inc. (101822682) Establishment Name Address ID/FEI Business Operations Zhejiang Medicare Pharmaceutical Co., Ltd. 421293835 manufacture(68345-817)