FDA.reportPublic FDA data

PROSHIELD ® PLUS Skin Protectant – dimethicone ointment

Manufacturer
Smith & Nephew, Inc.
Effective date
2020-08-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:16:45

Label at a glance#

ProductPROSHIELD PLUS SKIN PROTECTANT
Active ingredientDIMETHICONE
Label structure11 sections

Indications and uses

Helps prevent and temporarily protects chafed, chapped, or cracked skin.

Dosage and administration

Apply liberally as needed.

Storage and handling

Store at 20° – 25°C (68° – 77°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1% w/w

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps prevent and temporarily protects chafed, chapped, or cracked skin.

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

Apply liberally as needed.

Other information

STORAGE AND HANDLING SECTION

Store at 20° – 25°C (68° – 77°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Calcium/Sodium PVM/MA Copolymer (Gantrez MS-955), Polyethylene Glycol 400 NF, Polyethylene Glycol 3350 NF, Povidone USP.

Questions?

OTC - QUESTIONS SECTION

Please call 1-800-441-8227.

◊Trademark of Smith & Nephew

Certain Marks Reg. U.S. Pat. and Tm. Off.

Manufactured for: Smith & Nephew, Inc. Fort Worth, TX 76109

106683-0716

Internal Code 66801409

PRINCIPAL DISPLAY PANEL

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

#50484-044-09

NDC 50484-044-09

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

d26473d3-figure-01
d26473d3-figure-01

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50484-044-09GM - Gram50484-044fc33517c-0ed8-4d33-8c81-0fc8e2fbfd3712015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5P1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ1
POVIDONEINACTIVE INGREDIENTFZ989GH94E1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50484-04450484-044-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
POVIDONEFZ989GH94EIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 94 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POVIDONEPOVIDONEFZ989GH94ECAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EPOWDER, FOR SUSPENSION / ORAL35 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESOLUTION / ORAL3000 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAVENOUS24186 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUPPOSITORY / VAGINALNAExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSPRAY, METERED / NASAL96 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / ORAL900 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAMUSCULAR406 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRASYNOVIAL87 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, COATED PELLETS / ORAL10.03 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAMUSCULAR20.3 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION/ DROPS / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRAMUSCULAR87 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION, CONCENTRATE / ORAL2813 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / ORAL70200 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSPONGE / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / SUBCUTANEOUS2.88 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRALESIONAL87 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, ORALLY DISINTEGRATING / ORAL0.16 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQAEROSOL, POWDER / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / SUBCUTANEOUS2.88 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, EXTENDED RELEASE / ORAL56 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE PELLETS / ORAL32 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / ORAL20 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQLOTION / TOPICAL5 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESYSTEM / TOPICAL41 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / INTRA-ARTICULAR56 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION, SUSPENSION / SOFT TISSUE87 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET / SUBLINGUAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / RECTAL0.25 mg/mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCONCENTRATE / ORAL3000 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCREAM / TOPICAL10 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET / ORAL52 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PINJECTION / INTRAMUSCULAR56 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE / ORAL576 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAVENOUS28216 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, COATED / ORAL0.5 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESOLUTION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUSPENSION / ORAL400 mgExact identifier — unii candidate
36 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c07d1d5e-bfe1-43a6-a7e9-9c6ba1f0420133c9bffd-c629-4f65-bc59-2888fd4d6c3a2020-08-27WarningsExact identifier
spl id: c07d1d5e-bfe1-43a6-a7e9-9c6ba1f04201
spl set id: 33c9bffd-c629-4f65-bc59-2888fd4d6c3a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.