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]

SPL UNCLASSIFIED SECTION

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.

ASK DOCTOR

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

• 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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PROSHIELD PLUS  SKIN PROTECTANT
dimethicone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-044
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (OFF-WHITE)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-044-09	113 g in 1 TUBE; Type 0: Not a Combination Product	01/01/1997

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	01/01/1997

Labeler - Smith & Nephew Medical Ltd (216344051)

Establishment
Name	Address	ID/FEI	Business Operations
SPAN PACKAGING SERVICES D.B.A. MULTI-PACK SOLUTIONS		557434805	manufacture(69740-044)