CVS MAXIMUM STRENGTH ANTI-FUNGAL PEN 25% (UNDECYLENIC ACID) LIQUID [DENISON PHARMACEUTICALS, LLC]

CVS MAXIMUM STRENGTH ANTI-FUNGAL PEN 25% (UNDECYLENIC ACID) LIQUID [DENISON PHARMACEUTICALS, LLC]
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NDC 0295-9008-16
Set ID 7ee60b49-f12f-a0e1-e053-2991aa0a356e
Category HUMAN OTC DRUG LABEL
Packager Denison Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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)

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