Label: PROSHIELD PLUS SKIN PROTECTANT- dimethicone ointment

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated August 28, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Dimethicone 1% w/w

  • Purpose

    Skin Protectant

  • Uses

    Helps prevent and temporarily protects chafed, chapped, or cracked skin.

  • Warnings

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns


    For external use only.

    • When using this product do not get into eyes.
  • ASK DOCTOR

    Stop use and ask physician if 

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    Apply liberally as needed.

  • Other information

    Store at room temperature (15C°–25°C/59F°–77°F).

  • Inactive Ingredients

    Calcium/Sodium PVM/MA Copolymer (Gantrez MS-955), Polyethylene Glycol 400 NF, Polyethylene Glycol 3350 NF, Povidone USP.

  • Questions?

    Please call 1-800-441-1261.

  • SPL UNCLASSIFIED SECTION

    Smith & Nephew Medical Limited

    101 Hessle Road, Hull HU3 2BN England

    ◊Trademark of Smith & Nephew.

    Certain Marks Reg. U.S. Pat. and Tm. Off.

    Made in USA

    6566 18370

    Internal Code 66801409

  • PRINCIPAL DISPLAY PANEL

    REF 69740-044-09

    NDC 69740-044-09

    PROSHIELD◊ PLUS

    Skin Protectant
    Dimethicone 1% w/w

    PROSHIELD PLUS is a smooth, viscous, fragrance-free skin protectant, suitable for daily use. PROSHIELD PLUS adheres well to moist and dry skin and is easy to remove.

    Net wt 4 oz (113 g)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    7cd6c448-figure-01

  • INGREDIENTS AND APPEARANCE
    PROSHIELD PLUS  SKIN PROTECTANT
    dimethicone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-044
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITE (OFF-WHITE) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69740-044-09113 g in 1 TUBE; Type 0: Not a Combination Product01/01/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/1997
    Labeler - Smith & Nephew Medical Ltd (216344051)
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