Label: ELON DUAL DEFENSE ANTI FUNGAL FORMULA- undecylenic acid liquid

  • NDC Code(s): 71171-778-15
  • Packager: Little Giant Holdings LLC
  • 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 January 10, 2017

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

  • Drug Facts

  • Active ingredients:

    Undecylenic Acid 25.0%

    Purpose

    Antifungal

  • Uses

    Proven clinically effective in the treatment of most athletes's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). Helps prevent most athlete's foot with daily use.

    For effective relief of:

    Itching Burning 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.

  • Directions

    • Wash affected area well, and let product sit for 1-2 minutes before rinsing.
    • Make sure to dry affected area thoroughly.
    • Supervise children in the use of this product
    • For athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at leat once daily
    • Use 1-2 times daily.
    • Use daily for 4 weeks; if condition persists longer, ask a doctor
    • This product is not effective on the scalp or nails
  • Inactive ingredients:

    Aqua (Deionized Water), Calendula Officianalis Extract, Citrus Grandis (Grapefruit) Seed Extract, Ethyl Alcohol, Melaleuca Alternifolia (Tea Tree) Oil.

  • Other information

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

  • Package Labeling:

    ELON

  • INGREDIENTS AND APPEARANCE
    ELON DUAL DEFENSE ANTI FUNGAL FORMULA 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71171-778
    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
    WATER (UNII: 059QF0KO0R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CITRUS MAXIMA SEED (UNII: 083X55C543)  
    ALCOHOL (UNII: 3K9958V90M)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71171-778-151 in 1 BOX01/02/2017
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/02/2017
    Labeler - Little Giant Holdings LLC (080461006)