Label: SEUK- allantoin soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

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  • ACTIVE INGREDIENT

    Active ingredient: Allantoin 0.6%

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  • INACTIVE INGREDIENT

    Inactive ingredients:
    Coconut and Palm (Kernel/Oil), Jojoba Oil, Eriocephalus Punctulatus Oil, Phytosqualane, Grape Seed Oil, Tea Tree Oil, Aloe Barbadensis Leaf Extract, Tocopherol, Oriental Herb Extract, Perfume, Colloidal Silver, Organic Germanium, Organic Selenium, Platinum

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  • PURPOSE

    Purpose: Skin Protectant

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  • WARNINGS

    Warnings: Don't use if redness or irritation occur.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: Keep out of reach of babies and children.

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  • INDICATIONS AND USAGE

    Indication and usage: Do not place a lot of water or moisture before and after use.

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  • DOSAGE AND ADMINISTRATION

    Dosage and administration: Made enough foam with hands and rubbed on the face or body, and washing with water.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    SEUK 
    allantoin soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54170-130
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Allantoin (ALLANTOIN) Allantoin 0.6 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    COCONUT OIL  
    JOJOBA OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54170-130-01 100 g in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 02/01/2014
    Labeler - NANOPOLY CO., LTD. (687162537)
    Registrant - NANOPOLY CO., LTD. (687162537)
    Establishment
    Name Address ID/FEI Business Operations
    NANOPOLY CO., LTD. 687162537 manufacture(54170-130)
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