Mederma® Advanced Scar Gel

Mederma® Advanced Scar Gel

Drug Labeling and Warnings

Drug Details

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MEDERMA ADVANCED SCAR- allantoin gel 
Merz Pharmaceuticals, LLC

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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Mederma® Advanced Scar Gel

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

PRINCIPAL DISPLAY PANEL - 20 g Tube Box
MEDERMA ADVANCED SCAR 
allantoin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0259-1105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0259-1105-201 in 1 BOX11/01/201302/15/2020
120 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 0259-1105-501 in 1 BOX11/01/201302/15/2020
250 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 0259-1105-011 g in 1 PACKET; Type 0: Not a Combination Product11/01/201302/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/01/201302/15/2020
Labeler - Merz Pharmaceuticals, LLC (126209282)

Revised: 2/2020
 
Merz Pharmaceuticals, LLC


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