Label: HUMAN SCIENCE ANTIFUNGAL FOOT CARE- undecylenic acid liquid

  • 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 June 19, 2020

If you are a consumer or patient please visit this version.

  • 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 finalpart333C06/14/2020
    Labeler - HUMAN SCIENCE, LLC (080575466)