Mederma ®Advanced Scar Gel (Packaged by Pharma Packaging Solutions, LLC dba Tjoapack LLC)

Mederma Advanced Scar by

Drug Labeling and Warnings

Mederma Advanced Scar by is a Otc medication manufactured, distributed, or labeled by Pharma Packaging Solutions, LLC dba Tjoapack LLC, Merz Pharma GmbH & Co. KGaA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDERMA ADVANCED SCAR- allantoin gel 
Pharma Packaging Solutions, LLC dba Tjoapack LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Mederma ®Advanced Scar Gel
(Packaged by Pharma Packaging Solutions, LLC dba Tjoapack LLC)

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 productdo 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

MEDERMA ADVANCED SCAR 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75929-182
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: 75929-182-91	1 in 1 BOX	11/01/2013	05/31/2024
1		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
unapproved drug other		11/01/2013	05/31/2024

Labeler - Pharma Packaging Solutions, LLC dba Tjoapack LLC (928861723)

Establishment
Name	Address	ID/FEI	Business Operations
Merz Pharma GmbH & Co. KGaA		342543179	manufacture(75929-182)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Packaging Solutions, LLC dba Tjoapack LLC		928861723	pack(75929-182)

Revised: 3/2024

Document Id: 13a0478a-b171-3d6d-e063-6394a90a9679

34390-5

Set id: 13a0217f-255f-32d3-e063-6394a90ab5e8

Version: 1

Effective Time: 20240314

 

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