Mederma ® Advanced Scar Gel

Manufacturer: Merz Pharmaceuticals, LLC
Effective date: 2022-02-22
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-01 22:07:48

Label at a glance#

ProductMederma Advanced Scar

Active ingredientAllantoin

Label structure10 sections

Dosage and administration

Apply as needed.

Storage and handling

Store at room temperature

Contacts and useful links#

PhoneLabel contact1-888-925-8989

Websitewww.mederma.com

www.mederma.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

INDICATIONS & USAGE SECTION

Temporatrily protects and helps relieve chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition worsens
Symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

Deep or puncture wounds
Animal bites
Serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 20 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SKIN CARE FOR SCARS™
MEDERMA^®
ADVANCED
SCAR
GEL

NET WT. 0.70 OZ. (20g)

MERZ

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0259-1105-01	2022-02-25	C162847	48780-1	9d75b9d0-bac4-f424-e053-dadaa90a57ce	Mederma ® Advanced Scar Gel
0259-1105-20	2022-02-25	C162847	48780-1	9d75b9d0-bac4-f424-e053-dadaa90a57ce	Mederma ® Advanced Scar Gel
0259-1105-50	2022-02-25	C162847	48780-1	9d75b9d0-bac4-f424-e053-dadaa90a57ce	Mederma ® Advanced Scar Gel
0259-1105-01	2022-01-28	C162847	48780-1	9d75b9d0-bac4-f424-e053-dadaa90a57ce	Mederma ® Advanced Scar Gel
0259-1105-20	2022-01-28	C162847	48780-1	9d75b9d0-bac4-f424-e053-dadaa90a57ce	Mederma ® Advanced Scar Gel
0259-1105-50	2022-01-28	C162847	48780-1	9d75b9d0-bac4-f424-e053-dadaa90a57ce	Mederma ® Advanced Scar Gel
0259-1105-01	2020-02-07	C162847	48780-1	9d75b9d0-bac4-f424-e053-dadaa90a57ce	Mederma ® Advanced Scar Gel
0259-1105-20	2020-02-07	C162847	48780-1	9d75b9d0-bac4-f424-e053-dadaa90a57ce	Mederma ® Advanced Scar Gel
0259-1105-50	2020-02-07	C162847	48780-1	9d75b9d0-bac4-f424-e053-dadaa90a57ce	Mederma ® Advanced Scar Gel
0259-1105-01	2020-01-31	C162847	48780-1	9d75b9d0-bac4-f424-e053-dadaa90a57ce	Mederma ® Advanced Scar Gel
0259-1105-20	2020-01-31	C162847	48780-1	9d75b9d0-bac4-f424-e053-dadaa90a57ce	Mederma ® Advanced Scar Gel
0259-1105-50	2020-01-31	C162847	48780-1	9d75b9d0-bac4-f424-e053-dadaa90a57ce	Mederma ® Advanced Scar Gel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0259-1105-20	GM - Gram	0259-1105	337b4923-8a27-48d9-9f59-58a2e48c1110	1	2021-11-09
0259-1105-50	GM - Gram	0259-1105	058a1193-15cf-46cc-aa8f-3aef92c9d56d	1	2021-11-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Allantoin	ACTIVE INGREDIENT	344S277G0Z	2
Allantoin	ACTIVE MOIETY	344S277G0Z	2
Alcohol	INACTIVE INGREDIENT	3K9958V90M	2
Egg Phospholipids	INACTIVE INGREDIENT	1Z74184RGV	2
Hyaluronate Sodium	INACTIVE INGREDIENT	YSE9PPT4TH	2
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	2
Onion	INACTIVE INGREDIENT	492225Q21H	2
Panthenol	INACTIVE INGREDIENT	WV9CM0O67Z	2
Polyethylene Glycol 200	INACTIVE INGREDIENT	R95B8J264J	2
Sorbic Acid	INACTIVE INGREDIENT	X045WJ989B	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Mederma Advanced Scar
Allantoin
Water
Polyethylene Glycol 200
Alcohol
Xanthan Gum
Onion
Egg Phospholipids
Methylparaben
Sorbic Acid
Panthenol
Hyaluronate Sodium

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0259-1105	0259-1105-20, 0259-1105-50, 0259-1105-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Allantoin	344S277G0Z	ACTIB
Water	059QF0KO0R	IACT
Polyethylene Glycol 200	R95B8J264J	IACT
Alcohol	3K9958V90M	IACT
Xanthan Gum	TTV12P4NEE	IACT
Onion	492225Q21H	IACT
Egg Phospholipids	1Z74184RGV	IACT
Methylparaben	A2I8C7HI9T	IACT
Sorbic Acid	X045WJ989B	IACT
Panthenol	WV9CM0O67Z	IACT
Hyaluronate Sodium	YSE9PPT4TH	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 200 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	SOLUTION / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	TABLET / SUBLINGUAL	0.16 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	SOLUTION/ DROPS / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Egg Phospholipids	EGG PHOSPHOLIPIDS	1Z74184RGV	INJECTION, EMULSION / INTRAVENOUS		12852 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	TABLET, FILM COATED / ORAL		5 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Egg Phospholipids	EGG PHOSPHOLIPIDS	1Z74184RGV	EMULSION / INTRAVENOUS	1.2 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Hyaluronate Sodium	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
16b107d5-a7b0-4165-9dea-8b6f97371f17			7cf1c5a8-d28a-48c2-8cba-a3e18a7d51f9	2022-02-22	Warnings	Exact identifier spl id: 16b107d5-a7b0-4165-9dea-8b6f97371f17 spl set id: 7cf1c5a8-d28a-48c2-8cba-a3e18a7d51f9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.