FUNGI NAIL TOE AND FOOT ANTI-FUNGAL (UNDECYLENIC ACID) SOLUTION [DENISON PHARMACEUTICALS, LLC.]

FUNGI NAIL TOE AND FOOT ANTI-FUNGAL (UNDECYLENIC ACID) SOLUTION [DENISON PHARMACEUTICALS, LLC.]
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NDC 0295-9032-05, 0295-9032-11, 0295-9032-16
Set ID 8140da3a-a179-0299-e053-2a91aa0a1454
Category HUMAN OTC DRUG LABEL
Packager Denison Pharmaceuticals, LLC.
Generic Name
Product Class
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT


    Active ingredient....................Purpose

    Undecylenic Acid.....................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 Solution over affected area twice daily (morning and night) or as directed by a doctor. ■ The brush applicator allows for easy application under nails and surrounding 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. ■ 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

    label

  • INGREDIENTS AND APPEARANCE
    FUNGI NAIL TOE AND FOOT ANTI-FUNGAL 
    undecylenic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9032
    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:0295-9032-051 in 1 CARTON02/06/2019
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0295-9032-161 in 1 CARTON02/06/2019
    23 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    3NDC:0295-9032-111 in 1 CARTON02/06/2019
    31.7 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 finalpart333C02/06/2019
    Labeler - Denison Pharmaceuticals, LLC. (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC.001207208manufacture(0295-9032)

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