DERMAL WOUND CLEANSER- benzethonium chloride spray

Dermal Wound Cleanser by

Drug Labeling and Warnings

Dermal Wound Cleanser by is a Otc medication manufactured, distributed, or labeled by Smith & Nephew Medical Ltd., Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS

benzethonium chloride 0.13%

PURPOSE

First aid antiseptic

USES

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

WARNINGS

• 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

DIRECTIONS

• 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

• contains antimicrobial ingredient 

INACTIVE INGREDIENTS

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

QUESTION OR COMMENTS?

1 800 876-1261

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

Smith&Nephew

#449000
NDC 69740-490-00

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. (473mL)

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

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

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. (236mL)

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

INGREDIENTS AND APPEARANCE

DERMAL WOUND CLEANSER 
benzethonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-490
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	1.3 g  in 981 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-490-00	473 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/01/1994

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/1994

DERMAL WOUND CLEANSER 
benzethonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-492
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	1.3 g  in 981 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-492-00	236 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/01/1991

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/1991

Labeler - Smith & Nephew Medical Ltd. (216344051)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	MANUFACTURE(69740-490, 69740-492)