Label: MAXIMUM STRENGTH ANTI FUNGAL TOLNAFTATE 1%- tolnaftate 1% liquid

  • NDC Code(s): 0295-9017-07
  • Packager: Denison Pharmaceuticals, LLC
  • 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 November 3, 2022

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  • ACTIVE INGREDIENT

    Active ingredient

    Tolnaftate 1%

  • PURPOSE

    Purpose

    Anti-fungal

  • INDICATIONS & USAGE

    Uses

    • Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • For effective relief of itching, burning and cracking.
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    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

    Stop use and ask a doctor if

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Clean affected area with soap and warm water and dry thoroughly.
    • Apply a thin layer of Fungi-Nail® Anti-Fungal Liquid over affected area twice daily (morning and night) or as directed by a doctor.
    • The brush applicator allows for easy application on skin around the nail and cuticle areas.
    • Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
    • For athlete's foot pay special attention to spaces between the toes.
    • For athlete's foot and ringworm, use daily for 4 weeks. For toe fungus, apply under nail and around cuticle areas. If condition persists longer, consult a doctor.
    • This product is not effective on the scalp or nails.
    • Supervise children in the use of this product.
  • OTHER SAFETY INFORMATION

    Other information: Store at room temperature 15°-30°C (59°-86°). Protect from freezing. If freezing occurs warm to room temperature.

  • INACTIVE INGREDIENT

    Inactive ingredient

    Aloe Vera Leaf, Benzoic Acid, Caprylyl Glycol, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Citric Acid, Dimethicone 350, Ethylhexyl Glycerin, Eucalyptol, Glycerin, Glyceryl Monostearate, Lavender Oil, Olive Oil, Phenoxyethanol, Poloxamer 188, Purified Water USP, Sodium Hydroxide, Tea Tree Oil, Triethyl Citrate

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH ANTI FUNGAL TOLNAFTATE 1% 
    tolnaftate 1% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9017
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-9017-071 in 1 BOX07/11/2019
    130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/11/2019
    Labeler - Denison Pharmaceuticals, LLC (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(0295-9017)