ZETA CLEAR ANTIFUNGAL (UNDECYLENIC ACID) SOLUTION [PURE SOURCE, LLC]

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ZETA CLEAR ANTIFUNGAL (UNDECYLENIC ACID) SOLUTION [PURE SOURCE, LLC]
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NDC 65121-789-15
Set ID 490b65ba-c9c2-17db-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Pure Source, LLC
Generic Name
Product Class
Product Number
Application Number PART333C
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  • DRUG FACTS:

  • Active Ingredient:

    Undecylenic Acid 10.00%

    Antifungal

  • Uses:

    For cure of most:

    - ring worm (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 2-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.

  • Directions:

    • Clean and dry affected area with soap and water and dry thoroughly.
    • 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 ring worm.  If condition persists for longer, consult a physician.
    • Intended for use by normally healthy adults only.  Persons under the age of 18, or those with highly sensitive or allergic skins hould use only as directed by physician.
    • This product is not meant to be applied directly to the scalp or nails.
  • Other Ingredients:

    Cymbopogon 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:

    image description

  • INGREDIENTS AND APPEARANCE
    ZETA CLEAR ANTIFUNGAL 
    undecylenic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-789
    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
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CLOVE OIL (UNII: 578389D6D0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-789-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product02/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/17/2017
    Labeler - Pure Source, LLC (080354456)
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