DERMAL WOUND CLEANSER- benzethonium chloride spray 
Smith & Nephew, Inc.

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.

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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
  • 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, consult a doctor
  • Stop use and consult 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
  • may be covered with a sterile bandage
  • if bandaged, 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 50484-490-00

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 for:
Smith & Nephew, Inc.
St. Petersburg, FL 33716
www.smith-nephew.com

Package Display - Bottle, Spray (473mL)


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

Smith&Nephew

#59449200
NDC 50484-492-00

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 for:
Smith & Nephew, Inc.
St. Petersburg, FL 33716
www.smith-nephew.com


Package Display - Bottle, Spray (236mL)

DERMAL WOUND CLEANSER 
benzethonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-492
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1.3 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH) 5 uL  in 1 mL
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 ug  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) 10 ug  in 1 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 30 ug  in 1 mL
WATER (UNII: 059QF0KO0R) 927 uL  in 1 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) 15 ug  in 1 mL
CITRIC ACID ACETATE (UNII: DSO12WL7AU) 0.5 ug  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50484-492-00473 mL in 1.0 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package04/01/199406/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/199406/30/2018
DERMAL WOUND CLEANSER 
benzethonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-490
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1.3 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH) 5 uL  in 1 mL
WATER (UNII: 059QF0KO0R) 927 uL  in 1 mL
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 ug  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) 10 ug  in 1 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 30 ug  in 1 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) 15 ug  in 1 mL
CITRIC ACID ACETATE (UNII: DSO12WL7AU) 0.5 ug  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50484-490-00236 mL in 1.0 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package04/01/199106/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/199106/30/2018
Labeler - Smith & Nephew, Inc. (827731451)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933MANUFACTURE(50484-490, 50484-492)

Revised: 7/2016
Document Id: 4d90b12a-3b61-435a-b8e5-9deaa716360d
Set id: b48863b9-1afb-4edf-a67d-ccb21d29cce8
Version: 5
Effective Time: 20160722
 
Smith & Nephew, Inc.