Label: ANTIFUNGAL- miconazole nitrate cream
- NDC Code(s): 68345-817-25
- Packager: PSS World Medical, Inc.
- 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.
Updated September 27, 2012
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- Active Ingredient
Miconazole Nitrate 2%Close
Treats jock itch, ringworm, and athlete's foot.
INDICATIONS: Proven clinically effective in the treatment athlete's foot, jock itch and ringworm. Treats superficial skin infections caused by yeast. For effective relief of redness, irritation, itching, and burning.Close
For external use only.
PRECAUTIONS: For external use only. Not intended for ingestion. Avoid contact with eyes.
Stop use and ask a doctor if
Stop use and ask a doctor if
- irritation develops
- there is no improvement within 4 weeks for athlete's foot or ringworm
- or within 2 weeks for jock itch
Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- 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
- 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
- use daily for 2 weeks
This product is not effective on scalp or nails.Close
- Inactive Ingredients
BHT, Cetostearyl Alcohol, Glycerin, Glyceryl Stearate, Methylparaben, Magnesium Aluminum Silicate, Petrolatum, Propylparaben, Polyoxyl 40 Stearate, Purified Water.Close
Manufactured for PSS World Medical, Inc.
4345 Southpoint Blvd., Jacksonville, FL 32216
Comments or Questions? 800-777-4908
Made in ChinaClose
Store at room temperature 15-30C (59-86F).Close
- Package Label
- INGREDIENTS AND APPEARANCE
miconazole nitrate cream
Product 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)