Label: FUNGI NAIL TOE AND FOOT- undecylenic acid liquid

  • NDC Code(s): 55505-103-26, 55505-103-27
  • Packager: Kramer Laboratories
  • 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 1, 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 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 MEDICATON OUT OF 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 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 ingredient Isopropyl Palmitate

  • PRINCIPAL DISPLAY PANEL

    #1 Pharmacist Recommended

    MAXIMUM STRENGTH

    FUNGI-NAIL®

    ANTI-FUNGAL
    LIQUID


    Clinically Proven to Cure Fungal Infections

    TRIPLE ACTION FORMULA

    Kills Fungus
    Stops Itching & Burning
    Restores Skin Health

    CLINICALLY PROVEN MEDICINE

    1 FL. OZ (30 ML)

    Convenient and Easy to Apply

    Deep Penetrating Medicine that Stays in Place

    Not actual size.

    FUNGI-NAIL® ANTI FUNGAL LIQUID
    comes with a pinpoint brush applicator ideal for treating toe and foot fungus.

    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

    K1018

    Kramer Laboratories, Inc.
    Coral Gables, FL 33134
    kramerlabs.com
    funginail.com
    1-800-824-4894

    carton

    NDC#: 55505-103-26

    THE ORIGINAL
    FUNGI-NAIL®
    TOE & FOOT BRAND

    MAXIMUM STRENGTH ANTI-FUNGAL

    KILLS FUNGUS
    RESTORES SKIN

    1 FL. OZ. (30mL)

    Distributed By:
    KRAMER
    LABORATORIES

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

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

    K0318

    label
  • INGREDIENTS AND APPEARANCE
    FUNGI NAIL TOE AND FOOT 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-103
    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:55505-103-261 in 1 CARTON12/07/2010
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:55505-103-271 in 1 CARTON04/01/2018
    237 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/07/2010
    Labeler - Kramer Laboratories (122720675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dension Pharmecuticals001207208manufacture(55505-103)