FDA.reportPublic FDA data

Mederma Advanced Scar

Manufacturer
Pharma Packaging Solutions, LLC dba Tjoapack LLC | Merz Pharma GmbH & Co. KGaA
Effective date
2024-03-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:08:13

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

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 productdo 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

PRINCIPAL DISPLAY PANEL - 20 g Tube Box
PRINCIPAL DISPLAY PANEL - 20 g Tube Box

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75929-18275929-182-91

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
NameUNIIKind
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 200R95B8J264JIACT
ALCOHOL3K9958V90MIACT
XANTHAN GUMTTV12P4NEEIACT
ONION492225Q21HIACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
METHYLPARABENA2I8C7HI9TIACT
SORBIC ACIDX045WJ989BIACT
PANTHENOLWV9CM0O67ZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ALLANTOIN344S277G0ZACTIB

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
13a0478a-b171-3d6d-e063-6394a90a967913a0217f-255f-32d3-e063-6394a90ab5e82024-03-14WarningsExact identifier
spl id: 13a0478a-b171-3d6d-e063-6394a90a9679
spl set id: 13a0217f-255f-32d3-e063-6394a90ab5e8

Reported adverse events (FAERS/openFDA)#

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