PROSHIELD PLUS SKIN PROTECTANT- dimethicone ointment 
HEALTHPOINT, 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 protect chafed, chapped, cracked, dry skin.

Warnings

  • For external use only.
  • When using this product avoid contact with eyes.
  • If condition worsens or does not improve within 7 days, consult a physician.
  • Keep out of reach of children.

Directions

  • Apply liberally as often as necessary.

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.

Distributed by:
Healthpoint, Ltd.
San Antonio, Texas 78215
1-800-441-8227
www.healthpoint.com

Manufactured by:
DPT Laboratories, Ltd.
San Antonio, Texas 78215

REORDER NO. 0064-0300-04
102195-0801

PRINCIPAL DISPLAY PANEL

PROSHIELD® PLUS

SKIN PROTECTANT

NDC 0064-0300-04

PATENTED

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

d26473d3-figure-01
PROSHIELD PLUS  SKIN PROTECTANT
dimethicone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0064-0300
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:0064-0300-04113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/199708/31/2017
Labeler - HEALTHPOINT, LTD (965634504)

Revised: 12/2015
Document Id: 20b76693-71af-4c8c-ba1c-8bbb01888044
Set id: c0ecafa3-289c-47f6-87c7-400572b19120
Version: 2
Effective Time: 20151216
 
HEALTHPOINT, LTD