Label: FLUSH MAXIMUM STRENGTH ANTIFUNGAL FORMULA- undecylenic acid liquid

  • NDC Code(s): 80569-084-15
  • Packager: Triple Point Group, 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 November 12, 2021

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  • DRUG FACTS:

  • Active Ingredient

    Undecylenic Acid 25%

    Purpose

    Anti-fungal

  • Uses:

    For cure of most: • ringworm (tinea corporis) • athlete's foot (tinea pedis). For the relief of: • itching• scaling • cracking • burning • redness • soreness • irritation and discomforts which may accompany these conditions. 

  • Warnings:

    For external use only.

    Ask a doctor before use

    on children under two years of age

    DO NOT USE

    on diaper rash. 

    When using this product

    avoid contact with eyes.

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within four 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:

    • Clean and dry affected area with soap and water and dry throughly.
    • Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician.
    • For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks. For athlete's foot and ringworm. If Conditions persists for longer, consult a physician.
    • Intended for use typically by healthy adults only. Persons under the age of 18, or those with highly sensitive or allergic skin should use only as directed by physician.
    • This product is not meant to be applied directly to the Scalp or nails.
  • Other ingredients:

    Cymbopogan Nardus (Citronella) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Prunus Amygdalus Dulcis (Sweet
    Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzygium Aromaticum (Clovebud) Oil, Tocopheryl Acetate (Vitamin E).

  • Package Labeling

    Bottle

  • INGREDIENTS AND APPEARANCE
    FLUSH MAXIMUM STRENGTH ANTIFUNGAL FORMULA 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80569-084
    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
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CLOVE OIL (UNII: 578389D6D0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80569-084-1515 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/17/2020
    Labeler - Triple Point Group, LLC (058482713)
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