Label: CLOTRIMAZOLE 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 February 17, 2023

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  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete's foot, jock itch, and ringworm
    • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
  • Warnings

    Do not use on children under 2 years of age except under the advice and supervision of a doctor

    For external use only

  • When using this product

    avoid contact with the eyes

  • Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks(for athlete's foot and ringworm) or 2 weeks (for jock itch)
    • do not use for diaper rash
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wash affected area and dry thoroughly
    • apply a thin layer cover 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 the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day
    • for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
    • if conditions persist longer, ask a doctor
    • this product is not effective on the scalp or nails
  • Other information

    • store between 2°and 30° C (36° and 86° F)

  • Inactive ingredients

    butylated hydroxytoluene, carbomer 940, cetearyl alcohol, ethyl paraben, glycerin, glyceryl sterate, propylene glycol, purified water sodium dodecyl sulfate stearic acid

  • PRINCIPAL DISPLAY PANEL

    Clotrimazole

    carton

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0657
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    PROPYLENE GLYCOL 1-STEARATE (UNII: 32I3MRN561)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0657-11 in 1 BOX08/11/2011
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/11/2011
    Labeler - Kareway Product, Inc. (121840057)
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