CVS PHARMACY ANTI-FUNGAL PEN MAXIMUM STRENGTH (UNDECYLENIC ACID) LIQUID [CVS PHARMACY]

CVS PHARMACY ANTI-FUNGAL PEN MAXIMUM STRENGTH (UNDECYLENIC ACID) LIQUID [CVS PHARMACY]
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NDC 59779-965-01, 59779-965-02
Set ID 84493c06-248d-48fc-a59b-8a3cc078879d
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART333C
  • Active Ingredient

    Undecylenic Acid 25%

  • Purpose

    Anti-fungal

  • 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
  • Warnings

    For external use only

  • ASK DOCTOR

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

  • DO NOT USE

    Do not use on diaper rash

  • WHEN USING

    When using this product avoid contact with the eyes

  • STOP USE

    Stop use and ask 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 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
  • Other Information

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

    Isopropyl Palmitate, Propylparaben

  • Questions or Comments?

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

  • Image of Label and Carton

    CVSAntifungalPenLabel.jpg Label

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  ANTI-FUNGAL PEN MAXIMUM STRENGTH
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-965
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID250 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-965-021 in 1 BOX12/27/2012
    1NDC:59779-965-011.7 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/27/2012
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dhaliwal Laboratories,LLC016754201manufacture(59779-965)

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