FDA.reportPublic FDA data

Dermachange Scar Gel, Allantoin 0.5%

Manufacturer
Private Label Beauty and Wellness | Derma Care Research Labs, LLC | Derma Care Research Labs
Effective date
2024-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:24

Label at a glance#

ProductDermachange Scar
Active ingredientALLANTOIN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

OTC - PURPOSE SECTION

Skin Protectant.

DOSAGE & ADMINISTRATION SECTION

Temporarily protects and helps relieve chapped or cracked skin.

WARNINGS SECTION

For external use only.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Do not use on deep or puncture wounds, animal bites, and serious burns.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Apply as needed.

INACTIVE INGREDIENT SECTION

Water, Alcohol Denat., PEG-4, Propylene Glycol, Xanthan Gum, Allium Cepa (Onion) Bulk Extract, Panthenol, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Tocopherol, Glycerin, Juglans Nigra (Black Walnut) Leaf Extract, Ethylhexylglycerin, Benzyl Alcohol, Fragrance.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83520-297-00Dermachange Scar19.8 g in 1 TUBEGEL19.81
83520-297-00Dermachange Scar1 in 1 BOXGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83520-297DERMACHANGE SCAR (ALLANTOIN) GEL [PRIVATE LABEL BEAUTY AND WELLNESS]1Current NDC, 2 package rows20240307_12eed473-10d6-49c8-e063-6394a90afb63.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83520-29783520-297-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 200R95B8J264JIACT
TOCOPHEROLR0ZB2556P8IACT
PANTHENOLWV9CM0O67ZIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ONION492225Q21HIACT
ALLANTOIN344S277G0ZACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
XANTHAN GUMTTV12P4NEEIACT
ALOE VERA LEAFZY81Z83H0XIACT
BLACK WALNUT02WM57RXZJIACT
CHAMOMILEFGL3685T2XIACT
CUCUMBERYY7C30VXJTIACT
ALCOHOL3K9958V90MIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BENZYL ALCOHOLLKG8494WBHIACT
HYALURONATE SODIUMYSE9PPT4THIACT

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
Dermachange ScarALLANTOINPrivate Label Beauty and Wellness12eed473-10d6-49c8-e063-6394a90afb632024-03-05WarningsExact identifier
ndc (package): 83520-297-00
ndc (product): 83520-297
ndc11 (package): 83520029700
spl id: 12eed473-10d9-49c8-e063-6394a90afb63
spl set id: 12eed473-10d6-49c8-e063-6394a90afb63

Reported adverse events (FAERS/openFDA)#

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