FAMILY WELLNESS ANTIFUNGAL (TOLNAFTATE) CREAM [FAMILY DOLLAR]

FAMILY WELLNESS ANTIFUNGAL (TOLNAFTATE) CREAM [FAMILY DOLLAR]
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NDC 55319-638-28
Set ID 8cd1cf41-b414-4e7a-b244-8e7705c66ed5
Category HUMAN OTC DRUG LABEL
Packager Family Dollar
Generic Name
Product Class
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    Active Ingredient                                              Purpose

    Tolnaftate 1%................................................ Antifungal

  • PURPOSE

    Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • helps prevent most athlete's foot with daily use
    • for effective relief of itching, burning, and cracking
  • WARNINGS

    Warnings

    For external use only

  • 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
  • DO NOT USE

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

  • 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 thoroughlyapply 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 daily
    • use daily for 4 weeks; if conditions persist longer, ask doctor
    • to prevent athlete's foot, apply once or twice daily (morning and/or night)
    • this product is not effective on the scalp or nails
  • STORAGE AND HANDLING

    Other information

    • store between 20°C to 25°C (68°F to 77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, monorask sodium phosphate dilhydrate, propylene glycol, purified water, white petrolatum

  • 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 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-638
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MAGNESIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: H3992158BT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-638-281 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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