Label: SCARDERM- allantoin gel

  • NDC Code(s): 55264-050-01
  • Packager: Sinsin Pharmaceutical Co., Ltd.
  • 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 May 30, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Allantoin 1%

  • Purpose

    Skin Protectant

  • Use

    Temporatrily protects and helps relieve chapped or cracked skin

  • Warnings

    For external use only

    When using this product do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply as needed.

  • Other information

    Store at room temperature

  • Inactive Ingredients

    Water (purified), Allium Cepa (Onion) Bulb Extract, Heparin Sodium, Polyethylene Glycol, Concentrated Glycerin, Butylene Glycol, Sorbic Acid, Methylparaben, Jantangeom, Carbomer 940, Triethanolamine

  • Questions or Comments?

    For more information call 714-266-0391

  • PRINCIPAL DISPLAY PANEL - 20 g Tube Box

    PRINCIPAL DISPLAY PANEL - 20 g Tube Box
  • INGREDIENTS AND APPEARANCE
    SCARDERM 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Onion (UNII: 492225Q21H)  
    Heparin Sodium (UNII: ZZ45AB24CA)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Glycerin (UNII: PDC6A3C0OX)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Sorbic Acid (UNII: X045WJ989B)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Panthenol (UNII: WV9CM0O67Z)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Trolamine (UNII: 9O3K93S3TK)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-050-011 in 1 BOX05/30/2016
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34705/30/2016
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)
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