GADADERM ANTIFUNGAL (TOLNAFTATE) CREAM [GADAL LABORATORIES INC]

GADADERM ANTIFUNGAL (TOLNAFTATE) CREAM [GADAL LABORATORIES INC]
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NDC 53113-263-01
Set ID 3a798e01-e531-4d11-a388-cee3d1006b57
Category HUMAN OTC DRUG LABEL
Packager Gadal Laboratories Inc
Generic Name
Product Class
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    Active Ingredient                                   Purpose

    Tolnaftate 1%                                       Antifungal

  • PURPOSE

    Purpose

    Antifungal

  • INDICATIONS & USAGE

    Uses

    • Proven clinically to cure most:
    • Athlete's foot (tinea pedis)
    • Ringworm (tinea corporis)
    • Effectively soothes and relieves:
    • itching
    • burning
    • cracking
    • Helps prevent most athlete's foot from coming back with daily use.
  • WARNINGS

    Warnings: For External Use Only.

    Do not use on children under 2 years of age unless directed by a doctor.

    When using this product avoid contact with the eyes.

    Stop use and ask a doctor if

    • irritation occurs
    • There is no improvement within 4 weeks.
  • 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

  • DOSAGE & ADMINISTRATION

    Directions

    • Clean the affected area and dry thoroughly.
    • apply a thin layer over the 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 condition lasts longer, ask a doctor.
    • to prevent athlete's foot, apply to the feet once or twice daily (morning and/or night)
    • this product is not effective on the scalp or nails
  • INACTIVE INGREDIENT

    Inactive ingredients Mineral oil, propylene glycol, cety stearyl alcohol, purified water, ceteareth-6, stearyl alcohol, PEG-20 cetyl/stearyl ether, methylparaben, sodium m-bisulfite, propylparaben

  • QUESTIONS

    SSS Group LLC.

    Miami, Fl 33186

  • PRINCIPAL DISPLAY PANEL

    tolnaftate

  • INGREDIENTS AND APPEARANCE
    GADADERM ANTIFUNGAL 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-263
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    CETEARETH-6 (UNII: 2RJS3559D3)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BISULFITE (UNII: TZX5469Z6I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-263-011 in 1 BOX
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2013
    Labeler - Gadal Laboratories Inc (841305639)

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