FDA.reportPublic FDA data

SkinCeuticals Advanced Scar Control Skin Protectant

Manufacturer
L'Oreal USA Products Inc | Beauty Manufacturing Solutions Corp.
Effective date
2024-12-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:49:29

Label at a glance#

ProductSkinCeuticals Advanced Scar Control Skin Protectant
Active ingredientALLANTOIN
Label structure12 sections

Indications and uses

temporarily protects minor: cuts scrapes burns

Dosage and administration

● apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

temporarily protects minor:

  • cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

dimethicone, dimethicone crosspolymer, helianthus annuus (sunflower) seed oil unsaponifiables, silica silylate, acrylates/dimethicone copolymer, jojoba esters, helianthus annuus (sunflower) seed wax, acacia decurrens flower wax, polyglycerin-3

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

image of a carton
image of a carton
image of a carton
image of a carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1442087allantoin 0.5 % Topical GelPSN4
1442087allantoin 0.005 MG/MG Topical GelSCD4
1442087allantoin 0.5 % Topical GelSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-783-01SkinCeuticals Advanced Scar Control Skin Protectant1 in 1 CARTONGEL14
49967-783-01SkinCeuticals Advanced Scar Control Skin Protectant50 mL in 1 TUBEGEL504
49967-783-02SkinCeuticals Advanced Scar Control Skin Protectant4 mL in 1 TUBEGEL44
49967-783-03SkinCeuticals Advanced Scar Control Skin Protectant50 mL in 1 BOTTLEGEL504
49967-783-03SkinCeuticals Advanced Scar Control Skin Protectant1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-783SKINCEUTICALS ADVANCED SCAR CONTROL SKIN PROTECTANT (ALLANTOIN) GEL [L'OREAL USA PRODUCTS INC]4Current NDC, Legacy NDC, 5 package rows20241230_83f4bfbb-47d8-4fe9-ba33-85142ec6221c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-78349967-783-01, 49967-783-02, 49967-783-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZACTIB
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
SUNFLOWER OIL3W1JG795YIIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
POLYGLYCERIN-34A0NCJ6RD6IACT

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
SkinCeuticals Advanced Scar Control Skin ProtectantALLANTOINL'Oreal USA Products Inc83f4bfbb-47d8-4fe9-ba33-85142ec6221c2024-12-28WarningsExact identifier
ndc (package): 49967-783-03
ndc (package): 49967-783-02
ndc (package): 49967-783-01
ndc (product): 49967-783
ndc11 (package): 49967078302
ndc11 (package): 49967078303
ndc11 (package): 49967078301
spl id: ed1a7373-e1dc-4f6f-a2fc-5da01f1d3f35
spl set id: 83f4bfbb-47d8-4fe9-ba33-85142ec6221c

Reported adverse events (FAERS/openFDA)#

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