FAMILY CARE CLOTRIMAZOLE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [UNITED EXCHANGE CORP.]

FAMILY CARE CLOTRIMAZOLE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [UNITED EXCHANGE CORP.]
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NDC 65923-505-28
Set ID fc532ed7-27e4-4f2c-b77e-ba6c298763cd
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
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
    • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
  • 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 improvement 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 toes, wear well-fitting, ventilated shoes and changes shoes and socks at least once daily
    • 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
  • STORAGE AND HANDLING

    Other information

    Store between 20 o to 25 oC (68 o to 77 oF)

    Lot No. and Exp. Date: see box or see crimp of tube

  • INACTIVE INGREDIENT

    Inactive ingredients

    2-octyldodecanol, benzyl alcohol, cetaryl alcohol, cetyl esters, monobasic sodium phosphate dihydrate, polysorbate 60, propylene glycol, purified water, sorbitan stearate

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    505

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE CLOTRIMAZOLE ANTIFUNGAL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-505
    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
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-505-281 in 1 CARTON10/31/2016
    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 finalpart333C05/01/2012
    Labeler - United Exchange Corp. (840130579)

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