Scarderm by Sinsin Pharmaceutical Co., Ltd. SCARDERM- allantoin gel

Scarderm by

Drug Labeling and Warnings

Scarderm by is a Otc medication manufactured, distributed, or labeled by Sinsin Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SCARDERM 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55264-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55264-050-01	1 in 1 BOX	05/30/2016
1		20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	05/30/2016

Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)

Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)