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PROSHIELD PLUS SKIN PROTECTANT

Dosage form: ointment
Ingredients: DIMETHICONE 0.01g in 1g
Labeler: Smith & Nephew, Inc.
NDC Code: 50484-044

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.

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, 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.

Manufactured for:
Smith & Nephew, Inc.
Fort Worth, TX 76107

PROSHIELD is a registered trademark of Smith & Nephew, Inc.

REORDER NO. 0064-0300-04
140305-1114

PRINCIPAL DISPLAY PANEL

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
PROSHIELD PLUS  SKIN PROTECTANT
dimethicone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-044
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 3350 
POVIDONE 
Product Characteristics
ColorWHITE (OFF-WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50484-044-09113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/1997
Labeler - Smith & Nephew, Inc. (827731451)

Revised: 03/2015
 
Smith & Nephew, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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