Label: TM -TOLNAFTATE- tolnaftate 1% liquid

  • NDC Code(s): 83035-1260-3, 83035-1260-4
  • Packager: Singular Dreamer, Ltd dba True Marker
  • 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 August 11, 2023

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

  • Active ingredients

    Tolnaftate 1%

  • Purpose

    Topical Antifungal

  • Uses

    • Proven clinically effective in the treatment of most fungal infections including related/associated to tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm)
    • For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections
    • Prevents most tinea pedis (athlete’s foot) with daily use.
  • 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 eyes.
    • Stop use and ask a doctor, if irritation occurs of if there is no improvement within 4 weeks, discontinue use and consult a doctor (within 2 weeks for jock itch)
    • Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
    • If pregnant or breast-feeding, ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • clean the affected area and dry thoroughly
    • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
    • Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
    • 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.
  • Other information

    Protect the product in this container from excessive heat and direct sun.

  • Inactive ingredients

    Helianthus Annuus (Sunflower) Oil, Vitis Vinifera (Grape) Seed Oil, Mentha Piperita (Peppermint) Oil, Tocopheryl Acetate (Vitamin E), BHT (Butylated hydroxytoluene)

  • Questions?

    304-742-2433

  • Product label

    image description

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  • INGREDIENTS AND APPEARANCE
    TM -TOLNAFTATE 
    tolnaftate 1% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83035-1260
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83035-1260-31 in 1 CARTON03/28/2023
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:83035-1260-445 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/28/2023
    Labeler - Singular Dreamer, Ltd dba True Marker (129504103)
    Registrant - Singular Dreamer, Ltd dba True Marker (129504103)