Label: CVS PHARMACY ANTI-FUNGAL PEN MAXIMUM STRENGTH- undecylenic acid liquid 

  • Label RSS
  • NDC Code(s): 59779-965-01, 59779-965-02
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Undecylenic Acid 25%

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  • Purpose

    Anti-fungal

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  • Uses

    For the cure of most:

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

    For the relief of:

    • itching
    • scaling
    • crackling
    • burning
    • redness
    • soreness
    • irritation and discomfort 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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  • DO NOT USE

    Do not use on diaper rash

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  • WHEN USING

    When using this product avoid contact with the eyes

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  • STOP USE

    Stop use and ask 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 warnings and directions
    • use only as directed
    • clean the affected area with soap and water and dry thoroughly
    • remove cap from pen
    • twist the base of the pen, with brush pointing downward, until product dispenses
    • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
    • for athlete’s foot, pay special attention to spaces between the 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
    • this product is not effective on the scalp or nails
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  • Other Information

    • Store at 15°-30C° (59°-86°F)
    • Keep cap on pen when not in use
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  • Inactive Ingredients

    Isopropyl Palmitate, Propylparaben

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  • Questions or Comments?

    1-800-526-FOOT (3668) Mon-Fri 9AM - 5 PM EST

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  • Image of Label and Carton

    CVSAntifungalPenLabel.jpgLabel CVSAntiFungalPenCartonFinal.jpgCarton

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  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  ANTI-FUNGAL PEN MAXIMUM STRENGTH
    undecylenic acid liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-965
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID 250 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL PALMITATE  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-965-02 1 in 1 BOX
    1 NDC:59779-965-01 1.7 mL in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 12/27/2012
    Labeler - CVS Pharmacy (062312574)
    Registrant - Dhaliwal Labs (016754201)
    Establishment
    Name Address ID/FEI Business Operations
    Dhaliwal Labs 016754201 manufacture(59779-965)
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