Label: FUNGI NAIL TOE AND FOOT- tolnaftate ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2021

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

    ■ Clean affected areas with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail® Anti-Fungal Ointment 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. ■ To prevent athlete's foot, apply once or twice daily (morning and/or night). ■ For toe fungus, apply under nail and around cuticle area. 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.

  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    Inactive ingredients
    Aloe Vera Leaf, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Dimethicone 350, Eucalyptol, Lavender Oil, Glyceryl Monostearate, Olive Oil, Phenoxyethanol, Poloxamer 188, Purified Water USP, Sodium Hydroxide, Tea Tree Oil

  • PRINCIPAL DISPLAY PANEL

    MAXIMUM STRENGTH

    FUNGI-NAIL®
    ANTI-FUNGAL
    OINTMENT


    with brush applicator

    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

    NET WT 0.7 OZ (20 g)

    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 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

    Carton Label
  • INGREDIENTS AND APPEARANCE
    FUNGI NAIL TOE AND FOOT 
    tolnaftate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-185
    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
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: F68VH75CJC)  
    Dimethicone 350 (UNII: 2Y53S6ATLU)  
    Eucalyptol (UNII: RV6J6604TK)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-185-501 in 1 CARTON06/01/2019
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00511/15/2018
    Labeler - Kramer Laboratories (122720675)