PROSHIELD PLUS SKIN PROTECTANT- dimethicone ointment 
Smith & Nephew, Inc.

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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PROSHIELD® PLUS Skin Protectant – dimethicone ointment

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.

Stop use and ask physician if 

  • condition worsen
  • symptoms last more than 7 days or clear up and occur again within a few days.

  • 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 20° – 25°C (68° – 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 1-800-441-8227.

Trademark of Smith & Nephew

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

Manufactured for: Smith & Nephew, Inc. Fort Worth, TX 76109

106683-0716

Internal Code 66801409

PRINCIPAL DISPLAY PANEL

#50484-044-09

NDC 50484-044-09

PROSHIELD PLUS

Skin Protectant
Dimethicone 1% w/w

PROSHIELD PLUS is a smooth, viscous, greaseless, 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

d26473d3-figure-01

PROSHIELD PLUS  SKIN PROTECTANT
dimethicone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-044
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:50484-044-09113 g in 1 TUBE; Type 0: Not a Combination Product01/01/199711/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/199711/30/2022
Labeler - Smith & Nephew, Inc. (827731451)

Revised: 8/2020
 
Smith & Nephew, Inc.