DERMAL WOUND CLEANSER- benzethonium chloride spray
Smith & Nephew Medical Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Dermal Wound Cleanser

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
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 (473 mL)

Smith&Nephew

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

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)

DERMAL WOUND CLEANSER
benzethonium chloride spray

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Smith & Nephew Medical Ltd. (216344051)

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

Revised: 10/2020

Document Id: 3a8ea45b-d5cd-4b90-9dfe-d92e9728ea26

Set id: 18704cd5-1ecf-4e8c-9897-7e45394e68c8

Version: 3

Effective Time: 20201020

Smith & Nephew Medical Ltd.