MEDERMA ADVANCED SCAR- allantoin gel

Mederma Advanced Scar by

Drug Labeling and Warnings

Mederma Advanced Scar by is a Otc medication manufactured, distributed, or labeled by HRA Pharma America, Inc., Merz Pharma GmbH & Co KGaA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Allantoin 0.5%

Purpose

Skin Protectant

Uses

• Temporarily 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 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, PEG-4, Alcohol, Xanthan Gum, Allium Cepa (Onion) Bulb Extract, Panthenol, Fragrance, Lecithin, Methylparaben, Sorbic Acid, Sodium Hyaluronate

Questions or Comments?

• For more information call 1-833-426-6733 or visit www.mederma.com

PRINCIPAL DISPLAY PANEL

MEDERMA® ADVANCED SCAR GEL 

Clinically shown to visibly reduce the appearance of scars

No 1 Doctor & Pharmacist recommended scar brand

Skin Protectant

1 x GEL TUBE

NET WT. 1.76 Oz (50g)

Unique Triple-Action Formula penetrates into the skin

INGREDIENTS AND APPEARANCE

MEDERMA ADVANCED SCAR 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73302-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Polyethylene Glycol 200 (UNII: R95B8J264J)
Alcohol (UNII: 3K9958V90M)
Xanthan Gum (UNII: TTV12P4NEE)
Onion (UNII: 492225Q21H)
Sorbic Acid (UNII: X045WJ989B)
Panthenol (UNII: WV9CM0O67Z)
Egg Phospholipids (UNII: 1Z74184RGV)
Methylparaben (UNII: A2I8C7HI9T)
Hyaluronate Sodium (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73302-201-20	1 in 1 BOX	11/01/2013
1		20 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 73302-201-50	1 in 1 BOX	11/01/2013
2		50 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 Drug	M016	11/01/2013

Labeler - HRA PHARMA AMERICA, INC. (081160441)