FDA.reportPublic FDA data

Scartrate Cream

Manufacturer
Puretek Corporation
Effective date
2025-05-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:39:11

Label at a glance#

ProductScartrate Cream
Active ingredientDIMETHICONE, ALLANTOIN
Label structure9 sections

Indications and uses

Scartrate™ Cream is indicated for temporary protection and relief of chapped or cracked skin, it also effectively reduces the overall appearance of scars.

Dosage and administration

After cleansing, apply Scartrate™ Cream evenly to the affected area until it blends into the skin. Do not rinse off. Recommended for use in the morning (AM) and evening (PM). Reapply as needed to maintain skin protection and moisture.

Label contents#

Full prescribing information#

Description:

DESCRIPTION SECTION

Scartrate™ Cream contains 50 mg of Dimethicone and 22.5 mg of Allantoin per gram in a vehicle consisting of Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf (Aloe Vera) Juice, Aqua (Purified Water), Butylene Glycol, Carthamus Tinctorius (Safflower) Oil, Cetyl Alcohol, Dimethicone Crosspolymer, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (proprietary blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, sh-Polypeptide-121, Sodium Hydroxide, Stearic Acid, and Fragrance.

Indications and Usage:

INDICATIONS & USAGE SECTION

Scartrate™ Cream is indicated for temporary protection and relief of chapped or cracked skin, it also effectively reduces the overall appearance of scars.

Dosage and Administration:

DOSAGE & ADMINISTRATION SECTION

After cleansing, apply Scartrate™ Cream evenly to the affected area until it blends into the skin. Do not rinse off. Recommended for use in the morning (AM) and evening (PM). Reapply as needed to maintain skin protection and moisture.

Contraindications:

CONTRAINDICATIONS SECTION

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

Warnings and Precautions:

WARNINGS AND PRECAUTIONS SECTION

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

For external use only. Avoid contact with eyes. If the condition worsens, stop use and consult a licensed healthcare practitioner.

Adverse Reactions:

ADVERSE REACTIONS SECTION

No adverse reactions have been reported under normal conditions of use. If you experience any unusual reactions, discontinue use and consult your licensed healthcare practitioner.

Use in Specific Populations:

USE IN SPECIFIC POPULATIONS SECTION

Not specifically tested for use in pregnant or nursing women, children, or the elderly. Use caution and consult a licensed healthcare practitioner if you belong to one of these populations.

How Supplied:

HOW SUPPLIED SECTION

Scartrate™ Cream is supplied in a 3 oz (85 g) tube (NDC 59088-326-07) with CRC Cap.

Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Keep container tightly closed.

Use under the direction of a licensed healthcare practitioner. Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

LabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-326SCARTRATE CREAM (DIMETHICONE, ALLANTOIN) CREAM [PURETEK CORPORATION]3Unmatched20250509_1d666463-8294-5f78-e063-6294a90a91a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-326-07GM - Gram59088-3265f518628-1fb8-46b8-aa62-5cd0491f292012024-08-12

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-32659088-326-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT
KUKUI NUT OILTP11QR7B8RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MARINE COLLAGEN, SOLUBLE8JC99XGU4WIACT
SAFFLOWER OIL65UEH262ISIACT
GLYCERYL 1-STEARATE258491E1RZIACT
PEG-100 STEARATEYD01N1999RIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
DIMETHICONE92RU3N3Y1OACTIB
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
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
34956207-efbf-efdb-e063-6394a90a3b911d666463-8294-5f78-e063-6294a90a91a72025-05-07Warnings, Adverse reactionsExact identifier
spl id: 34956207-efbf-efdb-e063-6394a90a3b91
spl set id: 1d666463-8294-5f78-e063-6294a90a91a7

Reported adverse events (FAERS/openFDA)#

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