FDA.reportPublic FDA data

MEDERMA® Advanced Scar Gel

Manufacturer
PMI Branded Pharmaceuticals, Inc.
Effective date
2026-07-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-07-21 05:10:11

Label at a glance#

ProductMederma Advanced Scar
Active ingredientAllantoin
Label structure9 sections

Indications and uses

• Temporarily protects and helps relieve chapped or cracked skin

Dosage and administration

• Apply as needed

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve chapped or cracked skin

Warnings

WARNINGS SECTION

  • For external use only

When using this product

OTC - WHEN USING SECTION

  • 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 puncture wounds
  • Animal bites
  • Serious burns

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • Water, PEG-4, Alcohol, Xanthan Gum, Allium Cepa (Onion) Bulb Extract, Panthenol, Fragrance, Lecithin, Methylparaben, Sorbic Acid, Sodium Hyaluronate

Questions or Comments?

OTC - QUESTIONS SECTION

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEDERMA® ADVANCED SCAR GEL 

Clinically shown to visibly reduce the appearance of scars

No 1 Doctor & Pharmacist recommended scar brand

Skin Protectant

1 x GEL TUBE

NET WT. 1.76 Oz (50g)

Unique Triple-Action Formula penetrates into the skin

carton
carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73302-201-20GM - Gram73302-20119fcb90c-62f2-42e7-bf84-6e859b8b1ee112024-04-05

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
73302-20173302-201-20, 73302-201-50

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
Allantoin344S277G0ZACTIB
Water059QF0KO0RIACT
Polyethylene Glycol 200R95B8J264JIACT
Alcohol3K9958V90MIACT
Xanthan GumTTV12P4NEEIACT
Onion492225Q21HIACT
Sorbic AcidX045WJ989BIACT
PanthenolWV9CM0O67ZIACT
Egg Phospholipids1Z74184RGVIACT
MethylparabenA2I8C7HI9TIACT
Hyaluronate SodiumYSE9PPT4THIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-01-27full-release2026-06-01 00:53:44

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
Mederma Advanced ScarALLANTOINPMI Branded Pharmaceuticals, Inc.25bc1eae-3502-4c63-bd8a-43be2dfb0d6d2026-07-16WarningsExact identifier
ndc (package): 73302-201-50
ndc (package): 73302-201-20
ndc (product): 73302-201
ndc11 (package): 73302020120
ndc11 (package): 73302020150
spl id: 5916ff73-1d7c-416d-97ad-11038b1b5d2c
spl set id: 25bc1eae-3502-4c63-bd8a-43be2dfb0d6d

Reported adverse events (FAERS/openFDA)#

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