Label: SEUK- allantoin soap

  • 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 March 26, 2014

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  • ACTIVE INGREDIENT

    Active ingredient: Allantoin 0.6%

  • 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

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS AND USAGE

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

  • DOSAGE AND ADMINISTRATION

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SEUK 
    allantoin soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54170-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54170-130-01100 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2014
    Labeler - NANOPOLY CO., LTD. (687162537)
    Registrant - NANOPOLY CO., LTD. (687162537)
    Establishment
    NameAddressID/FEIBusiness Operations
    NANOPOLY CO., LTD.687162537manufacture(54170-130)
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