Label: FUNGICURE LIQUIDGEL- undecylenic acid gel

  • NDC Code(s): 52389-633-09
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • 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 March 8, 2016

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  • Active Ingredient

    Undecylenic acid 25% w/w

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  • Purpose

    Antifungal

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  • Uses

    For the cure of most

    • ringworm (tinea corporis)
    • athlete's foot (tinea pedis)

    For relief of

    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomforts which may accompany these conditions.
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  • Warnings

    For external use only



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  • ASK DOCTOR

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

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  • WHEN USING

    When using this product avoid contact with the eyes.

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  • Stop use and ask a doctor if


    • Irritation occurs
    • There is no improvement within 4 weeks.
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  • 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.

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  • 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 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 athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily.
    • For athlete's foot and ringworm, use daily for 4 weeks.  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.
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  • Other information

    • Fungicure may be applied to 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.
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  • Inactive ingredients

    Aloe vera gel, cyclomethicone, fragrance, isopropyl palmitate, silicon dioxide and vitamin E acetate.

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  • QUESTIONS

    Questions? 1-800-792-2582

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  • INGREDIENTS AND APPEARANCE
    FUNGICURE LIQUIDGEL 
    undecylenic acid gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-633
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Undecylenic acid (UNII: K3D86KJ24N) (Undecylenic acid - UNII:K3D86KJ24N) Undecylenic acid 250 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Aloe vera leaf (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52389-633-09 1 in 1 BOX
    1 9 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 11/30/2012
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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