Label: CVS MAXIMUM STRENGTH ANTI-FUNGAL PEN 25%- undecylenic acid liquid

  • NDC Code(s): 0295-9008-16
  • Packager: Denison Pharmaceuticals, LLC
  • 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 January 7, 2019

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  • ACTIVE INGREDIENT

    Active ingredient

    Undecylenic acid 25%

  • PURPOSE

    Purpose

    Anti-fungal

  • INDICATIONS & USAGE

    Uses

    For the cure of most

    • ringworm (tinea capitis)
    • 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 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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, 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; 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.
    • supervise children in the use of this product
    • this product is not effective on the scalp or nails
  • OTHER SAFETY INFORMATION

    Other information

    • Store at 15 o - 30 oC (59 o - 86 oF)
    • Keep cap on pen when not in use
  • INACTIVE INGREDIENT

    Inactive ingredient

    Isopropyl Palmitate

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    CVS MAXIMUM STRENGTH ANTI-FUNGAL PEN 25% 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-9008-163 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/09/2019
    Labeler - Denison Pharmaceuticals, LLC (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(0295-9008)