FDA.reportPublic FDA data

Skin Shield

Manufacturer
Insight Pharmaceuticals LLC
Effective date
2018-04-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:00:11

Label at a glance#

ProductSkin Shield
Active ingredientBENZETHONIUM CHLORIDE
Label structure10 sections

Indications and uses

first aid to help protect against infection in minor cuts, scrapes and burns

Dosage and administration

Adults and children 2 years of age and older: Clean the affected area. Dry thoroughly. Brush a small amount of product on the area 1 to 3 times daily and let dry. Hold knees, elbows, knuckles in bent position during application and drying. For more protection, apply second coat. Children under 2:   ask a doctor To remove: peel off or apply a fresh layer of product over dry product and using gauze, rub off gently w...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzethonium chloride 0.2%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Uses

INDICATIONS & USAGE SECTION

first aid to help protect against infection in minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only

Flammable keep away from fire or flame

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites, or serious burns

When using this product 

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older:

Clean the affected area. Dry thoroughly. Brush a small amount of product on the area 1 to 3 times daily and let dry. Hold knees, elbows, knuckles in bent position during application and drying. For more protection, apply second coat.

  • Children under 2: ask a doctor
  • To remove: peel off or apply a fresh layer of product over dry product and using gauze, rub off gently while still wet.

Other information

SPL UNCLASSIFIED SECTION

  • store at 15°-25°C (59°-77°F)
  • cap bottle tightly
  • keep carton for full drug facts

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetone, alcohol, amyl acetate, castor oil, drometrizole, dyclonine hydrochloride, ethyl acetate, pyroxylin

Questions? 

OTC - QUESTIONS SECTION

call 1-800-344-7239

©2017 Distributed by Insight Pharmaceuticals, LLC
Tarrytown, NY 10591, a Prestige Brands Company

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Skin Shield®
Liquid Bandage
First Aid Antiseptic 
0.45 fl oz (13.3 mL)

PRINCIPAL DISPLAY PANEL Skin Shield® Liquid Bandage First Aid Antiseptic 0.45 fl oz (13.3 mL)PRINCIPAL DISPLAY PANEL Skin Shield® Liquid Bandage First Aid Antiseptic 0.45 fl oz (13.3 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63736-292-452020-06-29C16284748780-19d75b9d0-5128-f424-e053-dadaa90a57ceSkin Shield
63736-292-452020-01-31C16284748780-19d75b9d0-5128-f424-e053-dadaa90a57ceSkin Shield

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63736-29263736-292-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZETHONIUM CHLORIDEPH41D05744ACTIB
ACETONE1364PS73AFIACT
ALCOHOL3K9958V90MIACT
AMYL ACETATE92Q24NH7ASIACT
CASTOR OILD5340Y2I9GIACT
DROMETRIZOLE5X93W9OFZLIACT
DYCLONINE HYDROCHLORIDEZEC193879QIACT
ETHYL ACETATE76845O8NMZIACT
PYROXYLINKYR8BR2X6OIACT

Source Document#

Source XML

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
7e6fcc0c-e835-4688-95d0-07e6a627c68b97249850-49af-4fa3-abfb-4f059f7e0fcc2020-07-02WarningsExact identifier
spl set id: 97249850-49af-4fa3-abfb-4f059f7e0fcc

Reported adverse events (FAERS/openFDA)#

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