FDA.reportPublic FDA data

Scarderm

Manufacturer
Sinsin Pharmaceutical Co., Ltd.
Effective date
2016-05-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:13

Label at a glance#

ProductScarderm
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 Ingredient

OTC - ACTIVE INGREDIENT SECTION

Allantoin 1%

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), Allium Cepa (Onion) Bulb Extract, Heparin Sodium, Polyethylene Glycol, Concentrated Glycerin, Butylene Glycol, Sorbic Acid, Methylparaben, Jantangeom, Carbomer 940, Triethanolamine

Questions or Comments?

OTC - QUESTIONS SECTION

For more information call 714-266-0391

PRINCIPAL DISPLAY PANEL - 20 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1045330allantoin 1 % Topical GelPSN1
1045330allantoin 0.01 MG/MG Topical GelSCD1
1045330allantoin 1 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac74f96-3910-44b9-8551-036880fbb1fbProduct name120260108
2c999b01-2a13-4eff-8eb4-00b87316ef79Product name120231116
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55264-050-012022-01-28C16284748780-1d6a99b39-9c19-a426-e053-dadaa90af4c2Scarderm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-050-01Scarderm20 g in 1 TUBEGEL201
55264-050-01Scarderm1 in 1 BOXGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-050SCARDERM (ALLANTOIN) GEL [SINSIN PHARMACEUTICAL CO., LTD.]1Legacy NDC, 2 package rows20160606_f2ce685d-4a58-4a89-83fd-ceb3cb185325.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55264-05055264-050-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
Allantoin344S277G0ZACTIB
Water059QF0KO0RIACT
Onion492225Q21HIACT
Heparin SodiumZZ45AB24CAIACT
Polyethylene Glycol 400B697894SGQIACT
GlycerinPDC6A3C0OXIACT
Butylene Glycol3XUS85K0RAIACT
Sorbic AcidX045WJ989BIACT
MethylparabenA2I8C7HI9TIACT
Xanthan GumTTV12P4NEEIACT
PanthenolWV9CM0O67ZIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
Trolamine9O3K93S3TKIACT

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
1898cb5a-7a8a-41f4-8864-d9a7f262677af2ce685d-4a58-4a89-83fd-ceb3cb1853252016-05-30WarningsExact identifier
spl id: 1898cb5a-7a8a-41f4-8864-d9a7f262677a
spl set id: f2ce685d-4a58-4a89-83fd-ceb3cb185325

Reported adverse events (FAERS/openFDA)#

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