FUNGICURE ANTI-FUNGAL LIQUID 25% (UNDECYLENIC ACID) LIQUID [DENISON PHARMACEUTICALS LLC]

FUNGICURE ANTI-FUNGAL LIQUID 25% (UNDECYLENIC ACID) LIQUID [DENISON PHARMACEUTICALS LLC]
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NDC 0295-9810-05, 0295-9810-10
Set ID 81dc6d51-968b-5093-e053-2991aa0a426f
Category HUMAN OTC DRUG LABEL
Packager Denison Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number PART333C
  • Active Ingredient

    Undecylenic acid 25% w/w

  • Purpose

    Antifungal

  • Uses

    For the cure of most

    • ringworm (tinea corporitis) and athlete's foot (tinea pedis).

    For relief of itching, scaling, cracking, burning, redness, soreness, irritation, and discomforts which may accompany these conditions.

  • Warnings

    For external use only.

  • ASK DOCTOR

    Ask a doctor before use on children under 2 years of age.

  • WHEN USING

    When using this product avoid contact with the eyes.

  • Stop use and ask a doctor if


    • Irritation occurs
    • There is no improvement within 4 weeks.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a poison control center right away.

  • Directions

    Read all package directions and warnings before use.
    Use only as directed.
    Clean the affected area with soap and warm water and dry thoroughly.
    Apply a thin layer of FUNGICURE Liquid over the affected area twice daily (morning and night), or as directed by a doctor.
    This product is not effective on scalp or nails.
    For ringworm and athlete's foot, use daily for 4 weeks.
    For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily.
    If condition persists longer, consult a doctor.
    Intended for use by normally healthy adults only.
    Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
    Supervise children in the use of this product.

  • Other information

    • FUNGICURE may be applied to exposed nail beds, cuticles, around nail edges and under nail tips where reachable with its applicator brush.
    • This product is not intended to, nor will it, penetrate hard nail surfaces.
    • While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use FUNGICURE until satisfactory results are obtained.
    • You may report serious side effects to the phone number provided under Questions? below.
  • Inactive ingredients

    Isopropyl palmitate

  • QUESTIONS

    Questions? 1-800-792-2582

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FUNGICURE ANTI-FUNGAL LIQUID 25% 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID250 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-9810-0528 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product02/20/2019
    2NDC:0295-9810-1038 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product02/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/20/2019
    Labeler - Denison Pharmaceuticals LLC (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals LLC001207208manufacture(0295-9810)

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