Label: THERASEAL- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated February 4, 2015

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  • 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

    PRINCIPAL DISPLAY PANEL - 6 ounce label
  • INGREDIENTS AND APPEARANCE
    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)
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