Label: FUCOIDAN SKINCURE- allantoin spray

  • 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 1.2%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Brown Seaweed(Fucoidan) Extrect, Cituspeel Extract, Mugwort Extract, Angelica, Cinnamon, Ascorbic acid, Coconut Oil, Sodium Hyalunonate, Silkpeptide, Glycerine, Calciam cabonate, 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

  • INDICATIONS AND USAGE

    Indication and usage:
    Apply morning and evening on skin and spray in the skin slightly.
    Suitable for all skin weakened or simply dehydrated.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration:
    Appiy 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 SKINCURE 
    allantoin spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58986-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin1.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58986-010-01100 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(58986-010)
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