FUNGICURE LIQUIDGEL (UNDECYLENIC ACID) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]

FUNGICURE LIQUIDGEL (UNDECYLENIC ACID) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]
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NDC 52389-633-09
Set ID ee5b4f26-0ed7-4e33-931e-8a31afa0cd9a
Category HUMAN OTC DRUG LABEL
Packager Alva-Amco Pharmacal Companies, Inc.
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 corporis)
    • athlete's foot (tinea pedis)

    For relief of

    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • 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 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.
  • 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.
  • Inactive ingredients

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

  • QUESTIONS

    Questions? 1-800-792-2582

  • PRINCIPAL DISPLAY PANEL

    Fungicure Liquid Gel Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    FUNGICURE LIQUIDGEL 
    undecylenic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-633
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52389-633-091 in 1 BOX06/05/2016
    19 g 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 finalpart333C11/30/2012
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

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