QUALITY CHOICE CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]

QUALITY CHOICE CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]
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NDC 63868-595-28
Set ID c3f36ba3-476f-4727-ac31-fe28251aecd1
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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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