Label: ETADERM ADVANCED ANTIFUNGAL SUPPORT- undecylenic acid cream

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

Drug Label Information

Updated March 13, 2024

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  • Drug Facts

  • Active ingredient

    Undecylenic Acid 25.00%

    Purpose

    Antifungal

  • Uses:

    • For the cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm).
    • For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections.
  • Warnings:

    For external use only

    Do not use

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

    When using this product

    • Avoid contact with eyes.

    Stop use and ask a doctor if

    • If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor (within 2 weeks for jock itch).

    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 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 arthlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks 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 no effective on the scalp or nails.
  • Other Information:

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

    Aloe Extract, Eugenia Caryophyllus (Clove) Bud Oil, Helianthus Annuus (Sunflower) Oil, Malaleuca Alternifolia (Tea Tree) Oil, Menthol, Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate (Vitamin E).

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ETADERM ADVANCED ANTIFUNGAL SUPPORT 
    undecylenic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84180-471
    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
    ALOE (UNII: V5VD430YW9)  
    CLOVE OIL (UNII: 578389D6D0)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    MENTHOL (UNII: L7T10EIP3A)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84180-471-0029 mL in 1 JAR; Type 0: Not a Combination Product03/25/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/25/2024
    Labeler - NUEPHASE LLC (118900101)
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