ANTISEPTIC FIRST AID- benzalkonium chloride and benzocaine spray 
Acme United Corp

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 0.1 %

Benzocaine 5.0%

Purpose

First aid antiseptic

Topical pain relief

Uses

First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

Warnings

For external use only. Flammable keep away from fire or flame

Do not use

  • near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or serious burns
  • over large areas of the body
  • more than one week unless directed by a doctor

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if condition persists or gets worse

Directions

Inactive ingredients

isopropyl alcohol, purified water

Questions?

call 203-857-5361

Principal Display Panel - Bottle Label

13-080

ANTISEPTICS

FIRST AID ONLY®

Antiseptic
First Aid Spray

Antiseptic first aid spray
with pain reliever for use
on minor cuts, scrapes
and burns

4 fl oz (118.3ml)

Principal Display Panel - Bottle Label
ANTISEPTIC FIRST AID 
benzalkonium chloride and benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0931
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1 mg  in 1 g
benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
isopropyl alcohol (UNII: ND2M416302)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-0931-01107 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/06/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/06/2014
Labeler - Acme United Corp (001180207)
Registrant - Safetec of America, Inc (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc874965262MANUFACTURE(0924-0931)

Revised: 10/2014
Document Id: ee9f7d04-0268-4256-a88d-99daae8eb4e9
Set id: 66b16c15-8b3f-4793-8c5f-3f85d65c8340
Version: 3
Effective Time: 20141006
 
Acme United Corp