FDA.reportPublic FDA data

TheraSeal

Manufacturer
Bausch Health US, LLC | DPT Laboratories, Ltd.
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:27:00

Label at a glance#

ProductTheraSeal
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

Helps prevent and temporarily protect chafed, chapped, cracked, dry skin.

Dosage and administration

Apply liberally as often as necessary.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1% w/w

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps prevent and temporarily protect chafed, chapped, cracked, dry skin.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

Not to be applied over deep or puncture wounds, infections or lacerations. If condition worsens or does not improve within 7 days, consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally as often as necessary.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, cyclomethicone, cyclomethicone aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol and polyglyceryl-4-isostearate and hexyl laurate, sodium chloride, imidurea.

SPL UNCLASSIFIED SECTION

U.S. Patent 5482714

Distributed by: Coria Laboratories, a division of Valeant Pharmaceuticals, North America, Fort Worth, TX 76107

Manufactured by: DPT Laboratories, Ltd., San Antonio, Texas 78215

106022-0410

PRINCIPAL DISPLAY PANEL - 6 ounce label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROTECTS DAMAGED HANDS

TheraSeal ®
Hand Protection

Protects hands from
harmful irritants

SKIN PROTECTANT

NET WT. 6 OZ.

Patented formulation

PRINCIPAL DISPLAY PANEL - 6 ounce label
PRINCIPAL DISPLAY PANEL - 6 ounce label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200010dimethicone 1 % Topical CreamPSN4
826807TheraSeal Hand Protection 1 % Topical CreamPSN4
826807dimethicone 10 MG/ML Topical Cream [TheraSeal Hand Protection]SBD4
200010dimethicone 10 MG/ML Topical CreamSCD4
200010dimethicone 1 % Topical CreamSY4
826807TheraSeal Hand Protection 1 % Topical CreamSY4
826807TheraSeal Hand Protection 10 MG/ML Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-1660-06TheraSeal170.1 g in 1 TUBECREAM170.14
0187-1660-06TheraSeal1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-1660THERASEAL (DIMETHICONE) CREAM [BAUSCH HEALTH US, LLC]4Current NDC, Legacy NDC, 2 package rows20241019_2c8dc616-20c1-4d33-8a89-9bcdb22b35c8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-1660-06GM - Gram0187-1660e155a7f3-9b28-4838-8789-bd9b308288c812015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DimethiconeACTIVE INGREDIENT92RU3N3Y1O1
DimethiconeACTIVE MOIETY92RU3N3Y1O1
CyclomethiconeINACTIVE INGREDIENTNMQ347994Z1
Hexyl LaurateINACTIVE INGREDIENT4CG9F9W01Q1
ImidureaINACTIVE INGREDIENTM629807ATL1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S71
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0187-16600187-1660-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
HEXYL LAURATE4CG9F9W01QIACT
SODIUM CHLORIDE451W47IQ8XIACT
IMIDUREAM629807ATLIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ImidureaIMIDUREAM629807ATLCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CyclomethiconeCYCLOMETHICONENMQ347994ZCREAM / TOPICAL13 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CyclomethiconeCYCLOMETHICONENMQ347994ZCREAM / TOPICAL13 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ImidureaIMIDUREAM629807ATLCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
TheraSealDIMETHICONEBausch Health US, LLC2c8dc616-20c1-4d33-8a89-9bcdb22b35c82024-10-17WarningsExact identifier
ndc (package): 0187-1660-06
ndc (product): 0187-1660
ndc11 (package): 00187166006
spl id: 24ade6cc-c3b3-2d87-e063-6394a90afc61
spl set id: 2c8dc616-20c1-4d33-8a89-9bcdb22b35c8

Reported adverse events (FAERS/openFDA)#

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