THERASEAL- dimethicone cream 
Bausch Health US, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TheraSeal Hand Protection

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

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

PRINCIPAL DISPLAY PANEL - 6 ounce label
THERASEAL 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-1660
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone1.7 g  in 170.10 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cyclomethicone (UNII: NMQ347994Z)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
Hexyl Laurate (UNII: 4CG9F9W01Q)  
Sodium Chloride (UNII: 451W47IQ8X)  
Imidurea (UNII: M629807ATL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-1660-061 in 1 CARTON01/01/2012
1170.10 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2012
Labeler - Bausch Health US, LLC (831922468)
Establishment
NameAddressID/FEIBusiness Operations
DPT Laboratories, Ltd.832224690MANUFACTURE(0187-1660)

Revised: 2/2015
Document Id: 430356b8-84d8-42e0-b458-d2ea26d6f246
Set id: 2c8dc616-20c1-4d33-8a89-9bcdb22b35c8
Version: 3
Effective Time: 20150204
 
Bausch Health US, LLC