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.

Drug Label Information

Updated September 27, 2012

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Miconazole Nitrate 2%

    Close
  • Purpose

    Antifungal

    Close
  • Uses

    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
  • Warnings

    ​For external use only.

    ​PRECAUTIONS:​ For external use only. Not intended for ingestion. Avoid contact with eyes.

    Do not use

    Do not use on children under 2 years of age unless directed by a doctor.

    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.

    Close
  • 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.

    Close
  • Inactive Ingredients

    BHT, Cetostearyl Alcohol, Glycerin, Glyceryl Stearate, Methylparaben, Magnesium Aluminum Silicate, Petrolatum, Propylparaben, Polyoxyl 40 Stearate, Purified Water.

    Close
  • Questions

    Manufactured for PSS World Medical, Inc.

    4345 Southpoint Blvd., Jacksonville, FL 32216

    Comments or Questions? 800-777-4908

    Made in China

    Close
  • Storage

    Store at room temperature 15-30C (59-86F).

    Close
  • Package Label

    NDC 68345-817-25

    6391 Each

    6391 Each

    6391 Box

    6391 Box

    Close
  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL 
    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)
    Close