PROSHIELD PLUS SKIN PROTECTANT- dimethicone ointment 
Smith & Nephew Medical Ltd

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


For external use only.

Stop use and ask physician if 

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.

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

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)

Revised: 8/2020
Document Id: d0c8d3b3-0ea3-44f2-8685-1f0a51270f5b
Set id: 7cd6c448-a5ed-4fc2-8b32-fea6096c3ac1
Version: 1
Effective Time: 20200828
 
Smith & Nephew Medical Ltd