Label: QUALITY CHOICE CLOTRIMAZOLE- 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 December 9, 2019

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  • ACTIVE INGREDIENT

    Active ingredient                                                                     Purpose

    Clotrimazole 1%.................................................................. Antifungal

  • PURPOSE

    Uses

    • cures most athlete's foot, jock itch, and ringworm
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

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

  • WHEN USING

    When using this product avoid contact with the eyes

  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there is no iprovement within 4 weeks (for athlete's foot and ringworm) or 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 immediately.

  • INDICATIONS & USAGE

    Directions

    • wash affected area and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night)
    • supervise children in the use of this product
    • for athlete's foot: pay special attention to spaces between the toesl; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    • if condition persists longer, ask a doctor
    • this product is not effective on the scalp or nails
  • STORAGE AND HANDLING

    Other information

    • store between 20° to 25°C (68° to 77°F)
    • Lot No. & Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients benzyl alcohol, cetanol, liquid paraffin, octyldodecanol, polysorbate 60, propylene glycol, purified water, sodium hydroxide, sodium monostearate, stearic acid, stearyl alcohol

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY C.D.M.A., INC.

    43157 W. NINE MILE

    NOVI, MI 48376-0995

    www.qualitychoice.com

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-595
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-595-281 in 1 CARTON01/20/2015
    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 finalpart333C01/19/2015
    Labeler - Chain Drug Marketing Association (011920774)
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