PROSHIELD ®PLUS Skin Protectant – dimethicone ointment

PROSHIELD PLUS by

Drug Labeling and Warnings

PROSHIELD PLUS by is a Otc medication manufactured, distributed, or labeled by Smith & Nephew Medical Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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 worsens
  • 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 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)  
CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%) (UNII: 5216H1HX5F)  
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 Product01/01/199706/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01601/01/199706/01/2024
Labeler - Smith & Nephew Medical Ltd (216344051)
Establishment
NameAddressID/FEIBusiness Operations
SPAN PACKAGING SERVICES D.B.A. MULTI-PACK SOLUTIONS557434805manufacture(69740-044)

Revised: 1/2025
Document Id: 2b43ca74-3f7e-279a-e063-6394a90afe85
Set id: 7cd6c448-a5ed-4fc2-8b32-fea6096c3ac1
Version: 5
Effective Time: 20250109