Label: FUCOIDAN ESSENCE- allantoin cream

  • 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 August 22, 2013

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  • ACTIVE INGREDIENT

    Active ingredient: Allantoin 2%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Brown Seaweed(Fucoidan) Extrect, Cituspeel Extract, Deer Amtlers Extract, Red Ginseng, Angelica, Cinnamon, Licorice, Glycerin, Sodium Hyalunonate, Coconut Oil, Cetyl alcohol, Xanthan Gum, Silkpeptide, EGF, Ascorbic acid, Titanium Oxide, Perfume, Methylparaben

  • PURPOSE

    Purpose: Skin protectant

  • WARNINGS

    Warning:
    Keep out of reach of children.
    For external use only.
    Avoid contact with eyes.
    Do not swallow.

  • 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:
    Apply morning and evening on face and neck and spread in the skin slightly.
    Suitable for all skin weakened or simply dehydrated.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration:
    Apply the recommended amount to your face and spread smoothly outwards, patting as your spread.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    FUCOIDAN ESSENCE 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58986-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin1 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    Xanthan Gum (UNII: TTV12P4NEE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58986-020-0150 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2013
    Labeler - SAMDAONE (688732888)
    Registrant - SAMDAONE (688732888)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAMDAONE688732888manufacture(58986-020)
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