Label: EMONINAIL ANTIFUNGAL- 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 10.00%

    Purpose

    Topical Antifungal

  • Uses

    Proven clinically effective in the treatment of most fungal infections related/associated to tinea pedis (athlete's foot) or tinea corporis (ringworm).

  • Warnings

    • For external use only

    Do not use

    • on children under 2 years of age, unless directed by a doctor.

    Stop use and ask a doctor if,

    • If irritation occurs or if 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.

    When using this product,

    avoid contact with eyes.

  • Directions

    • Wash the affected area and dry thoroughly.
    • Apply a thin layer of the product over affected 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 the toes; wear well-fitting, ventilated shoes, and change shoes andsocks at least once daily.
    • For athlete's foot and ringworm: use daily for 4 weeks. If condition persists longer, consult a doctor.
    • This product is not effective on the scalp or nails.
  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients

    Aqua (Deionized Water), SD-Alcohol 40B, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Alcohol, Polysorbate-20, Polycrylamide, C13-C14 Isoparaffin, Laureth-7, Glycerin, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Ethylhexyglycerin.

  • Other information

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

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    EMONINAIL ANTIFUNGAL 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-071
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-071-0824 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00505/01/2020
    Labeler - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-071)
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