FUNGI NAIL TOE AND FOOT (TOLNAFTATE) SOLUTION [KRAMER LABORATORIES]

FUNGI NAIL TOE AND FOOT (TOLNAFTATE) SOLUTION [KRAMER LABORATORIES]
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NDC 55505-177-26
Set ID a3ae043b-dc97-449b-b099-70bdf8e92482
Category HUMAN OTC DRUG LABEL
Packager Kramer Laboratories
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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) ■ 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. ■ The brush applicator allows for easy application on skin around the nail and cuticle area. ■ 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. ■ 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, 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

    NEW Improved Formula

    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

    CLINICALLY PROVEN INGREDIENT

    1 FL. OZ. (30mL)

    Convenient and Easy to Apply

    Deep Penetrating Medicine that Stays in Place

    Not actual size.

    Patent pending.

    #1 Pharmacist Recommended

    FUNGI-NAIL® ANTI-FUNGAL LIQUID 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.
    Bridgewater, NJ 08807
    kramerlabs.com
    funginail.com
    1-800-824-4894

    K1118

    carton

    NDC# 55505-177-26
     
    MAXIMUM STRENGTH 

    FUNGI-NAIL® ANTI-FUNGAL
    LIQUID

     
    KILLS FUNGUS
    RESTORES SKIN

    NET WT 1 FL. OZ. (30mL)

    Distributed By:
    KRAMER LABORATORIES

    Kramer Laboratories, Inc.
    Bridgewater, NJ 08807

    kramerlabs.com
    fungi-nail.com
    1-800-824-4894

    K1118

    Label
  • 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)  
    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
    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)

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