SOUNDBODY CLOTRIMAZOLE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [UNITED EXCHANGE CORP.]

SOUNDBODY CLOTRIMAZOLE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [UNITED EXCHANGE CORP.]
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NDC 65923-139-28
Set ID 3bfeaf9a-cdcc-4875-ba4d-613e834acb4c
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    Active ingredients                          Purpose

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

  • PURPOSE

    Uses

    • Cures most athletes 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 on children under 2 years of age unless directed by a doctor.

  • 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 right away.

  • 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 change shoes and socks at least once a day
    • for athlete's foot and ringwom use daily for 4 weeks; for jock itch; use daily for 2 weeks
    • 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

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

  • SPL UNCLASSIFIED SECTION

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    UNITED EXCHANGE CORP.

    17211 VALLEY VIEW AVE.

    CERRITOS, CA 90703 USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SOUNDBODY CLOTRIMAZOLE ANTIFUNGAL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-139
    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
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    MAGNESIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: H3992158BT)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-139-281 in 1 BOX10/04/2016
    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 finalpart333C02/26/2014
    Labeler - United Exchange Corp. (840130579)

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