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

FAMILY CARE ANTIFUNGAL (TOLNAFTATE) CREAM [UNITED EXCHANGE CORP.]
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NDC 65923-021-28
Set ID 6301ab99-1757-144a-e053-2a91aa0adb77
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
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
  • KEEP OUT OF REACH OF CHILDREN

    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. 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; well-fitting, ventilated shoes and change shoes and socks at least once daily
    • use daily for 4 weeks; if condition persists longer, ask a 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° to 25°C (68° to 77°F)
    • Lot No. & Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    cetostearly alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, purified water, sodium sulfite, stearth-20, stearic acid

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    5836 Corporate Ave.

    Cypress, CA 90630 USA

    1-800-814-8028

    Made in China

  • PRINCIPAL DISPLAY PANEL

    502

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE ANTIFUNGAL 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-021-281 in 1 CARTON01/02/2017
    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 finalpart333C01/02/2017
    Labeler - United Exchange Corp. (840130579)

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