UNDECYLENIC ACID LIQUID (ANTI-FUNGAL LIQUID) LIQUID [PREMIER BRANDS OF AMERICA INC.]

UNDECYLENIC ACID LIQUID (ANTI-FUNGAL LIQUID) LIQUID [PREMIER BRANDS OF AMERICA INC.]
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NDC 56104-114-30
Set ID e1b40b6a-2de3-4f07-883f-0ab6dbf6238d
Category HUMAN OTC DRUG LABEL
Packager Premier Brands of America Inc.
Generic Name
Product Class
Product Number
Application Number PART333C
  • ​Active ingredient

    Undecylenic acid 25%w/w

  • ​Purpose

    Antifungal

  • Uses

    For cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm).

    For relief of:

    • itching
    • burning
    • redness
    • irritation
    • scaling
    • soreness
    • discomfort which may accompany these conditions
  • Warnings

    For external use only

      consult a healthcare professional before use.

    Do not use

    ​on children 2 years of age unless directed by a doctor.

    When using this product

    avoid contact with eyes

    Use only as directed

    ​by a doctor on persons with highly sensitive skin.

    Stop use and consult a doctor if

    • there is no improvement within 4 weeks
    • irritation occurs

    Keep out of children.

    ​If accidental ingestion occurs, 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 and dry thoroughly
    • apply a thin layer of the product over the affecter area twice daily (morning and night) or as directed by a doctor
    • supervise children in the use of this product
    • for athlete's foot: pay special attention to spaces between 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 conditions persists longer, consult a doctor
    • this product is not effective on the scalp or nails
  • ​Other information​

    • store at room temperature 15°-30°C (59° - 86°F)
  • ​Inactive ingredient

    isopropyl palmitate

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    ​Premier Brands

    Maximum Strength

    Anti-Fungal Liquid

    ​25% Undecylenic acid

    Eliminates fungus on fingers, toes and around nails.

    ​Easy to apply applicator brush

    Dries quickly

    Non-oily, clear formula

    No unpleasant odor

    Net Contents: 1 FL OZ (30 mL)

    PB Anti-Fungal Nail Solution Liquid Box.jpgPB Anti-Fungal Nail Solution Liquid Label.jpg

  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID LIQUID 
    anti-fungal liquid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID0.25 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 0.75 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-114-3030 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2013
    Labeler - Premier Brands of America Inc. (117557458)

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