Label: FORMULA 7 THEGEL- tolnaftate gel

  • NDC Code(s): 49406-008-28, 49406-008-30
  • Packager: The Tetra Corporation
  • 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 January 28, 2020

If you are a consumer or patient 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 use on children under 2 years of age unless directed by a doctor.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding ask 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 finalpart333C06/13/2018
    Labeler - The Tetra Corporation (829958409)
    Registrant - The Tetra Corporation (829958409)