FDA.reportPublic FDA data

Skin Shield

Manufacturer
Insight Pharmaceuticals
Effective date
2010-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:24:56

Label at a glance#

ProductSkin Shield
Active ingredientBenzethonium Chloride, Dyclonine Hydrochloride
Label structure10 sections

Indications and uses

first aid for the temporary relief of pain and 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 years of age: Consult a doctor.

Storage and handling

To remove: peel off or apply a fresh layer of product over dry product and using gauze, rub off gently while still wet. Cap bottle tightly Store at room temperature 15°-25°C (59°-77°F). Keep carton for full drug facts.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Benzethonium chloride 0.2%First aid antiseptic
Dyclonine hydrochloride 0.75%Topical analgesic

Uses

INDICATIONS & USAGE SECTION

first aid for the temporary relief of pain and to help protect against infection in minor cuts, scrapes and burns.

Warnings

WARNINGS SECTION

For external use only

SPL UNCLASSIFIED SECTION

Flammable: Keep away from fire or flame

OTC - DO NOT USE SECTION

Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor. Do not use for longer than 1 week unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if the condition gets worse, or if symptoms persist for 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

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 years of age:

  • Consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • To remove: peel off or apply a fresh layer of product over dry product and using gauze, rub off gently while still wet.
  • Cap bottle tightly
  • Store at room temperature 15°-25°C (59°-77°F).
  • Keep carton for full drug facts.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetone, amyl acetate, castor oil, drometrizole, ethyl acetate, nitrocellulose, SD alcohol 40-B

Questions?

OTC - QUESTIONS SECTION

call 1-800-344-7239

SPL UNCLASSIFIED SECTION

Distributed by: Insight Pharmaceuticals Corp.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 26.6 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ECONOMY SIZE

Skin Shield®
Liquid Bandage
First Aid Antiseptic
Pain Reliever

NET WT. 0.9 fl oz (26.6 ml)

PRINCIPAL DISPLAY PANEL - 26.6 ml Bottle Carton
PRINCIPAL DISPLAY PANEL - 26.6 ml Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1048366benzethonium Cl 0.2 % / dyclonine HCl 0.75 % Topical SolutionPSN1
1053196Skin Shield 0.2 % / 0.75 % Topical SolutionPSN1
1053196benzethonium chloride 2 MG/ML / dyclonine hydrochloride 7.5 MG/ML Topical Solution [Skin Shield]SBD1
1048366benzethonium chloride 2 MG/ML / dyclonine hydrochloride 7.5 MG/ML Topical SolutionSCD1
1048366benzethonium Cl 0.2 % / dyclonine HCl 0.75 % Topical SolutionSY1
1053196Skin Shield (benzethonium Cl 0.2 % / dyclonine HCl 0.75 % ) Liquid BandageSY1
1053196Skin Shield (benzethonium Cl 0.2 % / dyclonine HCl 0.75 % ) Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1da7d10e-498b-41dd-970f-0f5bd7432f39Product name120190228

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63736-293-242019-10-21C16284748780-1956f9ecf-c441-621f-e053-dbdaa90a74adSkin Shield ® Liquid Bandage
63736-293-362019-10-21C16284748780-1956f9ecf-c441-621f-e053-dbdaa90a74adSkin Shield ® Liquid Bandage

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-293-24Skin Shield24 in 1 CASELIQUID241
63736-293-24Skin Shield1 in 1 BOXLIQUID11
63736-293-36Skin Shield36 in 1 CASELIQUID361
63736-293-36Skin Shield1 in 1 BOXLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-293SKIN SHIELD (BENZETHONIUM CHLORIDE AND DYCLONINE HYDROCHLORIDE) LIQUID [INSIGHT PHARMACEUTICALS]1Legacy NDC, 4 package rows20100630_bc596cfe-1229-42c1-940b-c40a81ead64f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzethonium ChlorideACTIVE INGREDIENTPH41D057441
Dyclonine HydrochlorideACTIVE INGREDIENTZEC193879Q1
BenzethoniumACTIVE MOIETY1VU15B70BP1
DyclonineACTIVE MOIETY078A24Q30O1
AcetoneINACTIVE INGREDIENT1364PS73AF1
Amyl AcetateINACTIVE INGREDIENT92Q24NH7AS1
Castor OilINACTIVE INGREDIENTD5340Y2I9G1
DrometrizoleINACTIVE INGREDIENT5X93W9OFZL1
Ethyl AcetateINACTIVE INGREDIENT76845O8NMZ1

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
63736-29363736-293-24, 63736-293-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzethonium ChloridePH41D05744ACTIB
Dyclonine HydrochlorideZEC193879QACTIB
Acetone1364PS73AFIACT
Amyl Acetate92Q24NH7ASIACT
Castor OilD5340Y2I9GIACT
Drometrizole5X93W9OFZLIACT
Ethyl Acetate76845O8NMZIACT

Source Document#

Source XML · Source PDF

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 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Castor OilCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
16 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZSOLUTION / TOPICAL31 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZSOLUTION / ORAL13 mgExact identifier — unii candidate
7 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GCAPSULE / ORAL1.04 mgExact identifier — unii candidate
16 equally ranked IID candidates
AcetoneACETONE1364PS73AFTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
Castor OilCASTOR OILD5340Y2I9GINJECTION, SOLUTION / INTRAMUSCULAR525 mgExact identifier — unii candidate
16 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GTABLET / ORAL17 mgExact identifier — unii candidate
16 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii candidate
16 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
16 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GSPRAY / NASALNAExact identifier — unii candidate
16 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GTABLET, EXTENDED RELEASE / ORAL23.27 mgExact identifier — unii candidate
16 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZSYSTEM / TRANSDERMAL41 mgExact identifier — unii candidate
7 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZSUSPENSION / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GTABLET, COATED / ORAL0.9 mgExact identifier — unii candidate
16 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GGRANULE, FOR SUSPENSION / ORAL128 mgExact identifier — unii candidate
16 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GGEL / NASAL429 mgExact identifier — unii candidate
16 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GINJECTION / INTRAMUSCULAR885 mgExact identifier — unii candidate
16 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZCAPSULE, EXTENDED RELEASE / ORAL382.26 mgExact identifier — unii candidate
7 equally ranked IID candidates
Ethyl AcetateETHYL ACETATE76845O8NMZFILM, EXTENDED RELEASE / TRANSDERMAL0.05 mgExact identifier — unii candidate
7 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GTABLET, FILM COATED / ORAL15.29 mgExact identifier — unii candidate
16 equally ranked IID candidates
Castor OilCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 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
6265bf84-0828-494b-b781-55351012e3e4bc596cfe-1229-42c1-940b-c40a81ead64f2010-06-22WarningsExact identifier
spl id: 6265bf84-0828-494b-b781-55351012e3e4
spl set id: bc596cfe-1229-42c1-940b-c40a81ead64f

Reported adverse events (FAERS/openFDA)#

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