Label: FORMULA 7 THEGEL- tolnaftate gel

  • NDC Code(s): 49406-008-28, 49406-008-30
  • Packager: The Tetra Corporation
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 12, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Uses:

    Antifungal 

  • INDICATIONS & USAGE

    For effective treatment of most athlete’s foot and ringworm.
    Relieves:

    • Itching

    • Scaling

    • Cracking
    • Redness

    • Soreness

    • Burning

    • Irritation

    Prevents the recurrence of most athlete’s foot (dermatophytosis) with daily use.

  • Active ingredient

    Tolnaftate 1%

  • Stop use and ask a doctor if:

    • When using for treatment of athlete’s foot or ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

    • When using for the prevention of athlete’s foot: If irritation occurs, discontinue use and consult a doctor.

  • DO NOT USE SECTION

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feedingask a health professional before use.

  • Questions or comments?

    1-800-826-0479
    9:00 AM to 5:30 PM EST.

  • Inactive Ingredients

    Inactive Ingredients: Water (aqua),C12-15 Alkyl Benzoate, SimmondsiaChinensis (Jojoba) Oil, Glycerin,Oleth-10, Oleth-5, Oleth-3 Phosphate,PEG-20 Hydrogenated Lanolin,Butylene Glycol, Urea, Ethoxydiglycol,N-Acetyl-L-Cysteine, TocopherolAcetate (Vitamin E), Melaleuca
    Alternifolia (Tea Tree) Oil, DisodiumEDTA, Ethylhexylglycerin, CaprylylGlycol, Phenoxyethanol, Aminomethylpropanediol,Sodium Chloride.

  • Directions:

    For treatment of athlete’s foot and ringworm:

    • Clean the affected area and dry thoroughly. Apply a thin layer of the product over the 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 daily.
    • For athlete’s foot and ringworm, use daily for 4 weeks.
    • If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

    To prevent athlete’s foot:
    • Wash the feet and dry thoroughly.
    • Apply a thin layer of the product to the feet once or twice daily (morning and/or night).
    • Supervise children in the use of this product.
    • Pay special attention to spaces between the toes; wear well-fitting,ventilated shoes, and change shoes and socks at least once daily.

  • Other information

    Store at room temperature, 25ºC (77ºF).

  • Warnings

    For external use only.

    When using this product avoid contact with eyes.

  • 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.

  • Product Label

    Label

  • INGREDIENTS AND APPEARANCE
    FORMULA 7 THEGEL 
    tolnaftate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49406-008
    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
    WATER (UNII: 059QF0KO0R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLETH-10 (UNII: JD797EF70J)  
    OLETH-5 (UNII: 1GH33785AY)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    PEG-20 HYDROGENATED LANOLIN (UNII: 5PP3KJ4T6S)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    UREA (UNII: 8W8T17847W)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49406-008-3015 g in 1 PACKAGE; Type 0: Not a Combination Product06/13/2018
    2NDC:49406-008-2828 g in 1 JAR; Type 0: Not a Combination Product01/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/13/2018
    Labeler - The Tetra Corporation (829958409)
    Registrant - The Tetra Corporation (829958409)