SCARDERM- allantoin gel 
Sinsin Pharmaceutical Co., Ltd.

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.

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Scarderm

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
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)

Revised: 5/2016
Document Id: 1898cb5a-7a8a-41f4-8864-d9a7f262677a
Set id: f2ce685d-4a58-4a89-83fd-ceb3cb185325
Version: 1
Effective Time: 20160530
 
Sinsin Pharmaceutical Co., Ltd.