Label: FUNGI NAIL ANTI-FUNGAL PEN- tolnaftate liquid

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

Drug Label Information

Updated December 15, 2023

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.

  • INDICATIONS & USAGE

  • 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 water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail® Anti-Fungal 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 cuticle area. If condition persists longer, consult a doctor. ■ The 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. Medicine may appear white to off white.

  • INACTIVE INGREDIENT

    Inactive ingredients aloe vera (aloe barbadensis) gel, ascorbic acid (vitamin C), dimethicone, DMDM hydantoin, edetate disodium dihydrate, eucalyptol, glycerin, glyceryl stearate SE, lavender oil, mineral oil, olive oil, PEG-100 stearate, phenoxetol, propylene glycol, tea tree oil, titanium dioxide, tocopheryl acetate (vitamin E), xanthan gum, water

  • PRINCIPAL DISPLAY PANEL

    Maximum Strength Medicine

    MAXIMUM STRENGTH
    FUNGI-NAIL®
    ANTI-FUNGAL
    PEN


    CLINICALLY PROVEN TO CURE AND PREVENT 
    FUNGAL INFECTIONS

    MAXIMUM STRENGTH
    FUNGI-NAIL®

    PLUS
    Aloe & Tea Tree Oil

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

    PLUS Aloe & Tea Tree Oil

    CLINICALLY PROVEN
    INGREDIENT

    .101 FL OZ (3ml)

    Carton Front

    FUNGI-NAIL®
    Maximum Strength
    Anti-Fungal plus 5 Natural Oils:


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

    and antioxidants Vitamin E
    and Vitamin C

    Fungi-Nail® is Specially Formulated to
    Kill Fungus and Restore Skin Health

    Deep Penetrating Medicine that Stays in Place
    Convenient and Easy to Apply Pen Applicator

    Instructions for Use:
    Twist base with brush
    pointing upward to saturate
    brush. 
    If you do not hear a
    click, turn the other way. First
    time use may require several
    twists to initiate product flow.


    For best results treat around all toenails and
    in between toes.
    Not for nail or scalp fungus. Cures most athlete's foot.

    K0922

    DO NOT USE 
    IF NECKBAND
    IS BROKEN OR MISSING

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

    KRAMER
    LABORATORIES

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

    Carton Back
  • INGREDIENTS AND APPEARANCE
    FUNGI NAIL ANTI-FUNGAL PEN 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-193
    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)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Dmdm Hydantoin (UNII: BYR0546TOW)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Eucalyptol (UNII: RV6J6604TK)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Stearate Se (UNII: FCZ5MH785I)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Peg-100 Stearate (UNII: YD01N1999R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-193-511 in 1 CARTON03/01/2020
    13 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/01/2020
    Labeler - Kramer Laboratories (122720675)