UNDECYLENIC ACID (ANTI-FUNGAL LIQUID MAXIMUM STRENGTH) LIQUID [HUDSON HEALTH LLC]

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UNDECYLENIC ACID (ANTI-FUNGAL LIQUID MAXIMUM STRENGTH) LIQUID [HUDSON HEALTH LLC]
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NDC 72446-004-01
Set ID 4b6a8f23-bc1b-4cc3-be84-b91ad0f5e60e
Category HUMAN OTC DRUG LABEL
Packager Hudson Health LLC
Generic Name
Product Class
Product Number
Application Number PART333C
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  • 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:

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

  • Warnings

    For external use only.

    If pregnant or breastfeeding

    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 toeswear 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)
    • protect from freezing. If freezing occurs warm to room temperature
    • keep tightly closed when not in use
  • Inactive ingredient

    isopropyl palmitate

  • Questions?

    Call 1-877-237-0194

  • Principal Display Panel

    comfortzone

    maximum strength

    anti-fungal liquid

    undecylienic acid

    eliminates fungus on fingers, toes & around nails

    • easy to apply applicator brush
    • dries quickly
    • non-oily, clear formula
    • no unpleasant odor

    NET 1 FL. OZ (30mL)

    AF LiquidAF Liquid 2

  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    anti-fungal liquid maximum strength liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72446-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID7.5 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72446-004-0130 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/01/2018
    Labeler - Hudson Health LLC (081276171)
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