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 Merz Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Allantoin 0.5%

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), PEG 200, Alcohol, Xantham Gum, Allium Cepa (Onion) Bulb Extract, Lecithin, Methylparaben, Sorbic Acid, Panthenol, Sodium Hyaluronate, Fragrance

Questions or Comments?

For more information call 1-888-925-8989 or visit www.mederma.com

PRINCIPAL DISPLAY PANEL - 20 g Tube Box

SKIN CARE FOR SCARS™
MEDERMA®
ADVANCED
SCAR
GEL

NET WT. 0.70 OZ. (20g)

MERZ

INGREDIENTS AND APPEARANCE

MEDERMA ADVANCED SCAR 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0259-1105
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)
Egg Phospholipids (UNII: 1Z74184RGV)
Methylparaben (UNII: A2I8C7HI9T)
Sorbic Acid (UNII: X045WJ989B)
Panthenol (UNII: WV9CM0O67Z)
Hyaluronate Sodium (UNII: YSE9PPT4TH)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0259-1105-20	1 in 1 BOX	11/01/2013
1		20 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0259-1105-50	1 in 1 BOX	11/01/2013
2		50 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0259-1105-01	1 g in 1 PACKET; Type 0: Not a Combination Product	11/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	11/01/2013

Labeler - Merz Pharmaceuticals, LLC (126209282)