Label: ANTI-FUNGAL PEN CVS- undecylenic acid liquid

  • 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 December 12, 2017

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

  • Active ingredient                          Purpose


    Undecylenic Acid 25%..................Anti-fungal

  • PURPOSE

  • Uses

    For the cure of most • ringworm (tinea corporis) • athlete’s foot (tinea pedis) For the relief of: • itching • scaling • cracking
    •burning• redness • soreness • irritation and discomforts which may accompany these conditions

  • WARNINGS

    Warnings
    For external use only.
    Ask a doctor before use on children under 2 years of age
    When using this product avoid contact with eyes
    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 immediately.

  • DOSAGE & ADMINISTRATION

    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

  • INACTIVE INGREDIENT

    Inactive ingredients : Isopropyl Palmitate, Propylparaben

  • OTHER SAFETY INFORMATION

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

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    ANTI-FUNGAL PEN  CVS
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-835
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Undecylenic Acid (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) Undecylenic Acid25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-835-011 in 1 CARTON09/15/2016
    11.7 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/15/2016
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(59779-835) , label(59779-835)