Label: FUNGI NAIL TOE AND FOOT PEN- undecylenic acid liquid

  • 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 January 8, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Undecylenic acid 25%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.

  • 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 warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail® Toe & Foot® Anti-Fungal Solution 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 space between the toes. ■ For athlete's foot and ringworm, use daily for 4 weeks. ■  For toe fungus, apply under nail and 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 room temperature 15°-30°C (59°-86°F). Protect from freezing. If freezing occurs warm to room temperature.

  • INACTIVE INGREDIENT

    Inactive ingredient Isopropyl Palmitate

  • PRINCIPAL DISPLAY PANEL

    #1 Pharmacist Recommended

    MAXIMUM STRENGTH

    FUNGI-NAIL®

    ANTI-FUNGAL
    PEN


    Clinically Proven to Cure Fungal Infections


    MAXIMUM STRENGTH

    FUNGI-NAIL
    TRIPLE ACTION FORMULA
    ✓ Kills Fungus
    ✓ Stops Itching & Burning
    ✓ Restores Skin Health

    .101 FL OZ (3ml)

    Instructions for Use:
    Twist base with brush pointing downward to saturate brush (Figure1). If you do not hear a click, turn the other way. First time use may require several twists to initiate product flow. Please note product is clear: apply brush to skin to confirm proper dispersion of solution.

    FUNGI-NAIL ANTI-FUNGAL PEN is the No-Mess, No-Spill, targeted treatment pen applicator that delivers the right amount of treatment right where you need it.

    Fungi-Nail Is Specially Formulated:

    Clear water-resistant barrier locks medicine in.

    Kills fungus and restores skin.

    For best results treat around all toenails and in between toes.

    Not for nail or scalp fungus.

    Cures most athlete's foot.

    CLINICALLY PROVEN MEDICINE

    Convenient and easy to Apply Pen Applicator

    Deep Penetrating Medicine that Stays in Place

    Restores Skin Health

    K1018

    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.
    Coral Gables, FL 33134

    kramerlabs.com
    funginail.com

    1-800-824-4894

    carton

    25% UNDECYLENIC ACID

    NDC#: 55505-187-51

    THE ORIGINAL
    FUNGI-NAIL®
    TOE & FOOT® BRAND

    ANTI-FUNGAL SOLUTION PEN

    0.101 FL OZ (3mL)

    Directions: Clean affected area with soap and water. Dry thoroughly. Twist pen base to saturate brush, then only as needed. Do not over twist. Apply around cuticle and underneath the edge of the nail twice daily.

    Keep carton for complete information.

    K0317

    KRAMER LAORATORIES

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

    TWIST TOP TO BREAK SEAL OR PEEL HERE

    SEALED FOR YOUR PROTECTION

    FOR EXTERNAL USE ONLY.

    DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN, TORN OR MISSING.
     

    label
  • INGREDIENTS AND APPEARANCE
    FUNGI NAIL TOE AND FOOT PEN 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-187
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Undecylenic acid (UNII: K3D86KJ24N) (Undecylenic acid - UNII:K3D86KJ24N) Undecylenic acid250 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-187-511 in 1 CARTON04/17/2015
    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 finalpart333C04/17/2015
    Labeler - Kramer Laboratories (122720675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(55505-187)