Label: HUMAN SCIENCE ANTIFUNGAL FOOT CARE- undecylenic acid liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • Drug Facts

  • Active Ingredient

    Undecylenic Acid 25.00%

    Purpose

    Antifungal

  • Uses:

    • For effective relief of itching, burning and cracking.
  • Warnings:

    • For external use only.

    Do not use

    on children under 2 years of age except under the supervision of a doctor.

    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.

    If swallowed, get medical help or contact a Poison Control Center right away.

    If pregnant or breast feeding,

    ask a health professional before use.

  • Directions:

    • Wash affected area well, and dry thoroughly.
    • Supervise, children in the use of this product.
    • For arthlete's foot:pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change socks at least once daily.
    • Use 1-2 times daily or as directed by physician.
    • Use daily for 4 weeks; if condition persists longer, ask a doctor.
    • This product is not effective on the scalp or nails.
  • Inactive Ingredients:

    Dimethyl Sulfoxid (DMSO), Ethoxydigilcol, Eugenia Caryophyllus (Clove) Bud oil, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Melaleuca Alternifolia (Tea Tree) Oil, Methyl Salicylate, Thymus Vulgaris (Thyme) Extract.

  • Other Information:

    Store between 20° to 30°C (68° to 86°F)

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    HUMAN SCIENCE ANTIFUNGAL FOOT CARE 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71356-156
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID250 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CLOVE OIL (UNII: 578389D6D0)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    THYME (UNII: CW657OBU4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71356-156-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/14/2020
    Labeler - HUMAN SCIENCE, LLC (080575466)
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