Label: FUNGI NAIL TOE AND FOOT- tolnaftate solution

  • NDC Code(s): 55505-177-26, 55505-177-80
  • Packager: Kramer Laboratories
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 11, 2023

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

  • ACTIVE INGREDIENT


    Active IngredientPurpose
    Tolnaftate 1%Anti-fungal
  • INDICATIONS & USAGE

    Uses ■ Proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ■ Helps prevent most athlete's foot with daily use ■ For effective relief of itching, burning and cracking.

  • 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

    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 areas 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. ■ 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 area. If condition persists longer, consult a doctor. ■ To prevent athlete's foot, apply once or twice daily (morning and/or night). ■ This product is not effective on the scalp or nails. ■ Supervise children in the use of this product.

  • STORAGE AND HANDLING

    Other information
    Store at room temperature 15°-30°C (59°-86°F). 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

    MAXIMUM STRENGTH

    FUNGI-NAIL®
    ANTI-FUNGAL
    LIQUID


    CLINICALLY PROVEN TO
    CURE AND PREVENT
    FUNGAL INFECTIONS

    TRIPLE ACTION FORMULA
    ✓ Kills Fungus
    ✓ Stops Itching & Burning
    ✓ Restores Skin Health
       * Cures Most Athlete's Foot

    CLINICALLY PROVEN INGREDIENT

    PLUS
    Aloe & Tea Tree Oil

    1 FL. OZ. (30mL)

    Convenient and Easy to Apply

    Deep Penetrating Medicine that Stays in Place

    Not actual size.
    Patent pending.

    Maximum Strength Anti-Fungal

    PLUS
    5 natural oils:
    ○ aloe vera
    ○ tea tree
    ○ eucalyptol
    ○ lavender
    ○ olive oil

    For best results treat skin around all toenails and in between toes.

    Not for nail or scalp fungus.

    Cures most athlete's foot.

    For more information about Fungi-Nail® and money back guarantee, visit us at funginail.com

    Kramer Laboratories, Inc.
    Bridgewater, NJ 08807
    1-800-824-4894

    K1120

    MAXIMUM STRENGTH
    ANTI-FUNGAL LIQUID

    Maximum
    Strength
    Medicine



    Carton Label

    MAXIMUM STRENGTH

    FUNGI-NAIL®
    ANTI-FUNGAL
    SPRAY


    CLINICALLY PROVEN TO
    CURE AND PREVENT
    FUNGAL INFECTIONS

    TRIPLE ACTION FORMULA
    ✓ Kills Fungus
    ✓ Stops Itching & Burning
    ✓ Restores Skin Health
       + Cures Most Athlete's Foot

    CLINICALLY PROVEN INGREDIENT

    PLUS
    Aloe & Tea Tree Oil

    1 FL. OZ. (30mL)

    MAXIMUM
    STRENGTH


    FUNGI-NAIL®
    ANTI-FUNGAL
    SPRAY

    Spray Applicator
    Makes Application
    Easy With No Mess

    Deep Penetrating
    Medicine that Stays 
    in Place

    MAXIMUM
    STRENGTH

    FUNGI-NAIL®
    ANTI-FUNGAL
    SPRAY


    Infused with
    5 natural oils

    ○ aloe vera
    ○ tea tree
    ○ eucalyptol
    ○ lavender
    ○ olive oil

    For best results treat skin
    around all toenails and in
    between toes.

    Not for nail or scalp fungus.

    Cures most athlete's foot.

    For more information
    about Fungi-Nail® and
    money back guarantee,
    visit us at funginail.com

    Kramer Laboratories, Inc. Bridgewater, NJ 08807
    1-800-824-4894

    K0622

    Carton 55505-177-80

    MAXIMUM STRENGTH

    FUNGI-NAIL®
    ANTI-FUNGAL
    SPRAY


    CLINICALLY PROVEN TO
    CURE AND PREVENT
    FUNGAL INFECTIONS

    1 FL OZ (30mL)

    Distributed by:
    KRAMER
    LABORITORIES
    K0622

    Kramer Laboratories, Inc. Bridgewater, NJ 08807
    kramerlabs.com funginal.com 1-800-824-4894

    Label 55505-177-80
  • INGREDIENTS AND APPEARANCE
    FUNGI NAIL TOE AND FOOT 
    tolnaftate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: F68VH75CJC)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Dimethicone 350 (UNII: 2Y53S6ATLU)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Eucalyptol (UNII: RV6J6604TK)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Triethyl Citrate (UNII: 8Z96QXD6UM)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-177-261 in 1 CARTON03/25/2019
    130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:55505-177-801 in 1 CARTON12/10/2022
    230 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/25/2019
    Labeler - Kramer Laboratories (122720675)