FDA.reportPublic FDA data

Dermal Wound Cleanser

Manufacturer
Smith & Nephew Medical Ltd. | Swiss-American CDMO, LLC
Effective date
2024-07-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:15:15

Label at a glance#

ProductDermal Wound Cleanser
Active ingredientBENZETHONIUM CHLORIDE
Label structure10 sections

Indications and uses

first aid to help reduce the risk of infection in minor cuts, scrapes and burns aids in the removal of foreign materials such as dirt and debris

Dosage and administration

clean the affected area apply a small amount of this product on the area 1 to 3 times daily rinse as per normal protocol cover wound with sterile dressing or bandage as needed if applying dressing or bandage, let dry first

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Benzethonium Chloride 0.13%

PURPOSE

OTC - PURPOSE SECTION

First aid antiseptic

USES

INDICATIONS & USAGE SECTION

  • first aid to help reduce the risk of infection in minor cuts, scrapes and burns
  • aids in the removal of foreign materials such as dirt and debris

WARNINGS

WARNINGS SECTION

  • For external use only
  • 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, contact a doctor
  • Stop use and contact a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

OTC - WHEN USING SECTION

  • For external use only

OTC - DO NOT USE SECTION

  • Do not use in the eyesor apply over large areas of the body

OTC - STOP USE SECTION

  • In case of deep or puncture wounds, animal bites, or serious burns, contact a doctor
  • Stop use and contact a doctorif the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor

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 immediately

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount of this product on the area 1 to 3 times daily
  • rinse as per normal protocol
  • cover wound with sterile dressing or bandage as needed
  • if applying dressing or bandage, let dry first

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • contains antimicrobial ingredient 

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

benzyl alcohol, citric acid, disodium EDTA, glycerin, polyquaternium-10, polysorbate 20, sodium citrate, water

QUESTION OR COMMENTS?

OTC - QUESTIONS SECTION

1 800 876-1261

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - DERMAL WOUND CLEANSER BOTTLE, SPRAY (473 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Smith&Nephew

REF 449000
NDC69740-490-00

Dermal
Wound
Cleanser

First Aid Antiseptic

  • Helps reduce risk of infection in wounds and burns
  • Gentle wound cleansing
  • Safe and easy to use
  • pH-buffered
  • Non-irritating

16 fl. oz. (473 mL)

Made in the USA for Smith & Nephew Medical Ltd.
101 Hessle Road
Hull
HU3 2BN
England
www.smith-nephew.com

Package Display - Bottle, Spray (473mL)Package Display - Bottle, Spray (473mL)

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - DERMAL WOUND CLEANSER BOTTLE, SPRAY (236 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Smith&Nephew

#59449200

NDC 69740-492-00

Dermal
Wound
Cleanser

First Aid Antiseptic

  • Helps reduce risk of infection in wounds and burns
  • Gentle wound cleansing
  • Safe and easy to use
  • pH-buffered
  • Non-irritating

8 fl. oz. (236 mL)

Made in the USA for Smith & Nephew Medical Ltd.
101 Hessle Road
Hull
HU3 2BN
England
www.smith-nephew.com

Package Display - Bottle, Spray (236mL)Package Display - Bottle, Spray (236mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582205benzethonium chloride 0.13 % Topical SprayPSN5
582205benzethonium chloride 1.3 MG/ML Topical SpraySCD5
582205benzethonium chloride 0.13 % Topical SpraySY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69740-490-002024-07-15C16284748780-1f386c64a-2b85-0266-e053-dadaa90a7c1aDermal Wound Cleanser
69740-492-002024-07-15C16284748780-1f386c64a-2b85-0266-e053-dadaa90a7c1aDermal Wound Cleanser
69740-490-002023-01-30C16284748780-1f386c64a-2b85-0266-e053-dadaa90a7c1aDermal Wound Cleanser
69740-492-002023-01-30C16284748780-1f386c64a-2b85-0266-e053-dadaa90a7c1aDermal Wound Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69740-490-00Dermal Wound Cleanser473 mL in 1 BOTTLE, SPRAYSPRAY4735
69740-492-00Dermal Wound Cleanser236 mL in 1 BOTTLE, SPRAYSPRAY2365

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69740-490DERMAL WOUND CLEANSER (BENZETHONIUM CHLORIDE) SPRAY [SMITH & NEPHEW MEDICAL LTD.]5Current NDC, Legacy NDC, 1 package rows20240716_18704cd5-1ecf-4e8c-9897-7e45394e68c8.zip
69740-492DERMAL WOUND CLEANSER (BENZETHONIUM CHLORIDE) SPRAY [SMITH & NEPHEW MEDICAL LTD.]5Current NDC, Legacy NDC, 1 package rows20240716_18704cd5-1ecf-4e8c-9897-7e45394e68c8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69740-492-00ML - Milliliter69740-492b4861653-0c37-469c-a255-865ed7dc304d12025-01-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D057441
BENZETHONIUMACTIVE MOIETY1VU15B70BP1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
69740-49069740-490-00
69740-49269740-492-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB
POLYQUATERNIUM-10 (125 MPA.S AT 2%)L45WU8S981IACT
POLYQUATERNIUM-10 (125 MPA.S AT 2%)L45WU8S981IACT
BENZYL ALCOHOLLKG8494WBHIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM CITRATE1Q73Q2JULRIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB

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 4 · 188 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii+route
64 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii+route
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route
64 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route
52 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii+route
64 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii+route
52 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
64 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route
64 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / TOPICAL2 %w/wExact identifier — unii+route
32 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii+route
32 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii+route
32 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOAP / TOPICAL0.02 %w/wExact identifier — unii+route
36 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHEMULSION / TOPICAL2 %w/wExact identifier — unii+route
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route
64 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii+route
52 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii+dosage form
64 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route
32 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii+route
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii+route
64 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii+route
32 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii+route
52 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii+dosage form
52 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route
64 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / TOPICAL3.7 %w/wExact identifier — unii+route
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route
64 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii+route
64 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii+route
64 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii+route
64 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSHAMPOO / TOPICAL8 %w/wExact identifier — unii+route
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii+route
32 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii+route
36 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHEMULSION / TOPICAL2 %w/wExact identifier — unii+route
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / TOPICAL2 %w/wExact identifier — unii+route
32 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii+route
52 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii+route
36 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCLOTH / TOPICALNAExact identifier — unii+route
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii+route
64 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+route
64 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route
64 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCLOTH / TOPICALNAExact identifier — unii+route
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii+route
64 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii+route
52 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii+dosage form
64 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route
64 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOLUTION / TOPICAL15 %w/wExact identifier — unii+route
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii+route
64 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
64 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHEMULSION / TOPICAL2 %w/wExact identifier — unii+route
36 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSHAMPOO / TOPICAL8 %w/wExact identifier — unii+route
36 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii+route
52 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii+dosage form
52 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii+route
32 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii+route
32 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route
52 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCLOTH / TOPICALNAExact identifier — unii+route
36 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii+route
32 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOAP / TOPICAL0.02 %w/wExact identifier — unii+route
36 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route
36 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
4 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
Dermal Wound CleanserBENZETHONIUM CHLORIDESmith & Nephew Medical Ltd.18704cd5-1ecf-4e8c-9897-7e45394e68c82024-07-15WarningsExact identifier
ndc (package): 69740-492-00
ndc (package): 69740-490-00
ndc (product): 69740-490
ndc (product): 69740-492
ndc11 (package): 69740049000
ndc11 (package): 69740049200
spl id: 1d4e61fc-0bf2-fb51-e063-6294a90a21fe
spl set id: 18704cd5-1ecf-4e8c-9897-7e45394e68c8

Reported adverse events (FAERS/openFDA)#

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