FUNGI NAIL TOE AND FOOT MS (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT [KRAMER LABORATORIES]

FUNGI NAIL TOE AND FOOT MS (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT [KRAMER LABORATORIES]
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NDC 55505-179-50, 55505-179-55
Set ID 124670a3-60e3-422f-9705-2b17b6150efe
Category HUMAN OTC DRUG LABEL
Packager Kramer Laboratories
Generic Name
Product Class
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT


    Active IngredientPurpose
    Zinc Undecylenate 20%Anti-fungal
    Undecylenic acid 5%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® Toe & Foot® 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. ■ 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 Emulsifying wax NF, methylparaben, mineral oil, white petrolatum.

  • PRINCIPAL DISPLAY PANEL

    THE ORIGINAL
    FUNGI-NAIL®
    TOE & FOOT® BRAND

    MAXIMUM STRENGTH ANTI-FUNGAL

    STOPS SKIN FUNGUS AROUND NAILS

    KILLS FUNGUS RESTORES SKIN


    CURES Most Athlete's Foot

    SKIN PENETRATING OINTMENT

    0.7 FL. OZ. (20 g)

    Lasting ointment with dual-angled brush

    For best results treat around all toenails and in between toes

    Not for Nail or scalp fungus

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

    Ungüento con aplicador de brocha con doble ángulo

    Para mejores resultados aplique Fungi-Nail® alrededor de las uñas, y entre los dedos del pie

    Este product no es efectivo en el cuero cabelludo ni en las uñas
     
    K0118

    Certified
    WBENC
    Women's Business Enterprise

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

    carton

    NDC#: 55505-179-50

    THE ORIGINAL
    FUNGI-NAIL®
    TOE & FOOT® BRAND

    MAXIMUM STRENGTH ANTI-FUNGAL

    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
    funginail.com
    1-800-824-4894

    K0317

    label
  • INGREDIENTS AND APPEARANCE
    FUNGI NAIL TOE AND FOOT  MS
    zinc undecylenate undecylenic acid ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-179
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N) ZINC UNDECYLENATE4 g  in 20 g
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID1 g  in 20 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-179-501 in 1 CARTON05/11/2016
    120 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:55505-179-551 in 1 CARTON06/01/2018
    225 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/11/2016
    Labeler - Kramer Laboratories (122720675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmecuticals001207208manufacture(55505-179)