Label: GADADERM ANTIFUNGAL- tolnaftate 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 September 27, 2013

If you are a consumer or patient please visit this version.

  • 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)