Label: MICONAZOLE- antifungal cream

  • NDC Code(s): 50382-050-01
  • Packager: Galentic Pharma (India) Priva Te Limited
  • 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 July 23, 2013

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  • Active Ingredient

    Miconazole Nitrate 2%

  • Uses - Antifungal

    • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
    • For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
    • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.
  • Warnings

    Do not use:

    • Do not use on children under 2 years of age unless directed by a doctor.
    • Avoid contact with eyes.
    • For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
    • For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions



    • Supervise children in the use of this product.
    • If conditions persist longer, consult a doctor.
    • This product is not effective on scalp or nails.
  • Other information.

    Protect from freezing. Avoid excessive heat.

  • Directions

    • Clean the affected area and dry thoroughly. Apply a layer of cream over affected area twice daily (morning and night) or as directed by a doctor.
    • Foe athlete's foot and ringworm, use daily for 4 weeks.
    • For jock itch, use daily for 2 weeks.
    • For athlete's foot, pay special attention to spaces between toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
  • Inactive Ingredients

    Inactive Ingredients: Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, white soft paraffin.

  • Keep Out of Reach of Children

    • KEEP OUT OF REACH OF CHILDREN
    • If swallowed get medical help or contact a Poison Control Center.
  • Principal Display Panel

    Principal Display Panel

    Miconazole Nitrate Cream USP 2%


    Gal Miconazole.jpg

    Miconazole

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 
    antifungal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-050-0172 in 1 CASE
    11 in 1 BOX
    128.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/18/2013
    Labeler - Galentic Pharma (India) Priva Te Limited (918531450)