Label: FAMILY WELLNESS ANTIFUNGAL- 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 January 21, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient                                                 Purpose

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

  • PURPOSE

    Uses

    Relieves itching, burning, cracking, scaling, and discomfort

  • WARNINGS

    Warnings

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

  • WHEN USING

    When using this product avoid contact with eyes

  • STOP USE

    Stop use and ask a doctor if:

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's food and ringwood) or 2 weeks (for jock itch)
    • do not use for diaper rash
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • INDICATIONS & USAGE

    Directions

    • Wash affected area and dry thoroughly
    • Apply a thick layer over 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
    • In condition persists longer, ask a doctor
    • This product is no effective on the scalp or nails
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

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

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    FAMILY DOLLAR SERVICES INC.

    10401 MONROE RD.

    MATTHEWS, NC 28105 USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS ANTIFUNGAL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-626
    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
    2-OCTYLDODECYL PALMITATE (UNII: 6TBP0K24XM)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETEARYL BEHENATE (UNII: 7ARI9LTH0U)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    MAGNESIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: H3992158BT)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PEG-60 SORBITAN STEARATE (UNII: 073G38N8GC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-626-281 in 1 BOX
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/21/2014
    Labeler - Family Dollar (024472631)
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