Label: MICONAZOLE cream

  • 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 June 22, 2017

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

  • Active Ingredient

    Miconazole Nitrate 2%

  • Warnings

    For External Use Only

  • DO NOT USE

    Do not use

    • on children under 2 years of age unless directed by a doctor.
    • for diaper rash

    When using this product 

    • avoid contact with eyes
  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvementwithin 2 weeks when used for the treatment of jock itch
    • there is no improvementwithin 4 weeks when used for athletes foot or ringworm
  • Uses

    • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
    • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch or itching burning feet
  • Indications and Usage

    • Supervise children in the use of this product.
  • Other information.

    Store at room temperature

  • Directions

    • Clean the affected area and dry thoroughly. Apply a thin layer of cream over affected area twice daily (morning and night) or as directed by a doctor.
    • Supervise children in the use of this product
    • 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.
    • Foe athlete's foot and ringworm, use daily for 4 weeks.
    • For jock itch, use daily for 2 weeks.
    • If condition persists longer, consult a doctor.
    • This product is not effective on scalp or nails.
  • 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 right away
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    Preferred Plus Pharmacy

    Miconazole Nitrate Cream USP 2%

    KR Miconazole.jpg

    KR Miconazole

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 
    miconazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-050
    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:61715-050-0128.4 g in 1 TUBE; Type 0: Not a Combination Product03/22/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/21/2013
    Labeler - Kinray, Inc. (012574513)
    Registrant - Dynarex Corporation (008124539)