Label: FUNGICURE ANTI-FUNGAL LIQUID 25%- undecylenic acid liquid

  • NDC Code(s): 0295-9810-05, 0295-9810-10
  • Packager: Denison Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL

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 February 14, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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)