Label: FUNGI NAIL TOE AND FOOT- tolnaftate ointment

  • NDC Code(s): 0295-8604-56, 0295-8604-57
  • Packager: Denison Pharmaceurticals, 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 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 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 15°-30° C (59°-86° 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

    NEW Improved Formula



    MAXIMUM STRENGTH



    FUNGI-NAIL ®

    ANTI-FUNGAL

    OINTMENT



    CLINICALLY PROVEN TO

    CURE AND PREVENT

    FUNGAL INFECTIONS



    TRIPLE ACTION FORMULA

    ✓ Kills Fungus

    ✓ Stops Itching & Burning

    ✓ Restores Skin Health



    CLINICALLY PROVEN INGREDIENT



    0.7 FL. OZ. (20 g)



    Convenient and Easy to Apply



    Deep Penetrating Medicine that Stays in Place



    Not actual size.



    Patent pending.



    #1 Pharmacist Recommended



    FUNGI-NAIL ® ANTI-FUNGAL OINTMENT infused with 5 natural oils including tea tree, eucalyptol, aloe, olive and lavender



    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.

    Coral Gables, FL 33134

    kramerlabs.com

    funginail.com

    1-800-824-4894



    K1118

    carton

    MAXIMUM STRENGTH



    FUNGI-NAIL ®

    ANTI-FUNGAL

    OINTMENT



    KILLS FUNGUS • RESTORES SKIN



    NET WT 0.7 FL. OZ. (20 G)



    Distributed By:

    KRAMER LABORATORIES



    Kramer Laboratories, Coral Gables, FL 33134 U.S.A.



    kramerlabs.com

    fungi-nail.com

    1-800-824-4894



    K0918

    label

  • INGREDIENTS AND APPEARANCE
    FUNGI NAIL TOE AND FOOT 
    tolnaftate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-8604
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-8604-561 in 1 CARTON08/12/2019
    120 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0295-8604-571 in 1 CARTON08/12/201911/06/2019
    226.6 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/12/2019
    Labeler - Denison Pharmaceurticals, LLC (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmecuticals001207208manufacture(0295-8604)
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