THERASEAL- dimethicone cream

TheraSeal by

Drug Labeling and Warnings

TheraSeal by is a Otc medication manufactured, distributed, or labeled by Bausch Health US, LLC, DPT Laboratories, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Dimethicone 1% w/w

Purpose

Skin Protectant

Uses

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

Warnings

For external use only.

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.

Keep out of reach of children.

Directions

Apply liberally as often as necessary.

Inactive Ingredients

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

Questions?

1-866-819-9007
www.CoriaLabs.com

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

PROTECTS DAMAGED HANDS

TheraSeal®
Hand Protection

Protects hands from
harmful irritants

SKIN PROTECTANT

NET WT. 6 OZ.

Patented formulation

INGREDIENTS AND APPEARANCE

THERASEAL 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-1660
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	1.7 g  in 170.10 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cyclomethicone (UNII: NMQ347994Z)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Sodium Chloride (UNII: 451W47IQ8X)
Imidurea (UNII: M629807ATL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-1660-06	1 in 1 CARTON	01/01/2012
1		170.10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2012

Labeler - Bausch Health US, LLC (831922488)

Establishment
Name	Address	ID/FEI	Business Operations
DPT Laboratories, Ltd.		832224690	MANUFACTURE(0187-1660)