Indications and uses
Helps prevent and temporarily protects chafed, chapped, or cracked skin.
PROSHIELD ® PLUS Skin Protectant – dimethicone ointment
- Manufacturer
- Smith & Nephew Medical Ltd | SPAN PACKAGING SERVICES D.B.A. MULTI-PACK SOLUTIONS
- Effective date
- 2024-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:44:11
Label at a glance#
ProductPROSHIELD PLUS SKIN PROTECTANT
Active ingredientDIMETHICONE
Label structure14 sections
Dosage and administration
Apply liberally as needed.
Storage and handling
Store at room temperature (15C°–25°C/59F°–77°F).
Contacts and useful links#
Label contents#
Full prescribing information#
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.
OTC - ASK DOCTOR SECTION
Stop use and ask physician if
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- 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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69740-044-09 | 2024-07-12 | C162847 | 48780-1 | f386c649-f68c-0266-e053-dadaa90a7c1a | PROSHIELD ® PLUS Skin Protectant – dimethicone ointment |
| 69740-044-09 | 2023-01-30 | C162847 | 48780-1 | f386c649-f68c-0266-e053-dadaa90a7c1a | PROSHIELD ® PLUS Skin Protectant – dimethicone ointment |
Products#
Every source-derived product name is available through these pages.
- PROSHIELD PLUS SKIN PROTECTANT
- DIMETHICONE
- POLYETHYLENE GLYCOL 400
- POLYETHYLENE GLYCOL 3350
- POVIDONE
- CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69740-044 | 69740-044-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| POVIDONE | FZ989GH94E | IACT |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
| CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%) | 5216H1HX5F | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2b43ca74-3f7e-279a-e063-6394a90afe85 | 7cd6c448-a5ed-4fc2-8b32-fea6096c3ac1 | 2025-01-09 | Warnings | 7cd6c448-a5ed-4fc2-8b32-fea6096c3ac1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.