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
  • 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 December 10, 2022

If you are a consumer or patient 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 finalpart333C03/25/2019
    Labeler - Kramer Laboratories (122720675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmecuticals001207208manufacture(55505-177)