FAMILY WELLNESS ANTIFUNGAL (CLOTRIMAZOLE) CREAM [FAMILY DOLLAR]

FAMILY WELLNESS ANTIFUNGAL (CLOTRIMAZOLE) CREAM [FAMILY DOLLAR]
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NDC 55319-626-28
Set ID eb58bdeb-0ffb-4459-be0e-9b2b8c5e46e6
Category HUMAN OTC DRUG LABEL
Packager Family Dollar
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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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