Other
Drug Facts
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
Theraseal Cream
FDA Label NDC 0187-1660
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bausch Health Us, Llc for the product Theraseal (NDC 0187-1660). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, otc - do not use, otc - when using, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Dimethicone 1% w/w
Purpose
Skin Protectant
Uses
Helps prevent and temporarily protect chafed, chapped, cracked, dry skin.
Otc - Do Not Use
For external use only.
Otc - When Using
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
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
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)
* Please review the disclaimer below.
