STERILE ANTIBACTERIAL WOUND WASH  - benzalkonium chloride spray 
Ascot Pharmaceuticals, 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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Drug Facts


Active ingredients

Benzalkonium Chloride 0.13%

Purpose

First Aid Antiseptic

Uses

first aid to help prevent the risk of bacterial contamination in minor cuts, scrapes and burns.

Warnings


For external use only


Do not use



  • in eyes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Ask a doctor before use

in the event of deep puncture wounds, animal bites or severe burns

When using this product

use only as directed

Stop use and ask a doctor if


  • conditions worsens
  • symptoms persists for more than seven days
  • symptoms disappear and reappear again within a few days

Keep out of reach of childrens

If swallowed get medical help or contact a Poison Control Center right away

Directions


Other information


Inactive ingredients

Sodium Chloride U.S.P., Aloe Barbadensis Leaf Extract , Purified Water

Questions?

1-800-831-7210 

Principal Display Panel

NDC 70043-390-04

Ascot Pharmaceutical Inc.

Sterile Antibacterial

WOUND WASH

FIRST AID CLEANSER

ECO-FRIENDLY

No Fluorinated Hydrocarbon Propellants



3600 CONTINUOUS SPRAY

4 FL.OZ (120 mL)

Label





STERILE ANTIBACTERIAL WOUND WASH  
benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70043-390
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70043-390-04120 mL in 1 CAN; Type 0: Not a Combination Product06/23/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/23/2016
Labeler - Ascot Pharmaceuticals, Inc. (079915219)
Establishment
NameAddressID/FEIBusiness Operations
BOV Solutions Inc800463486manufacture(70043-390)

Revised: 6/2016
Document Id: 817e487e-fe10-46a2-ac08-b324856690f1
Set id: 71b24e53-0e25-4ad6-b754-80c06c2dcfac
Version: 1
Effective Time: 20160623
 
Ascot Pharmaceuticals, Inc.