ANTISEPTIC- benzalkonium chloride, benzocaine spray 
Provision Medical

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

Principal Display Panel – 2 fl. oz Packet Label

The Provision
First Aid
Line™

Antiseptic Spray

For Temporary Pain
Relief and to Help
Prevent Infection in
Minor Cuts, Scrapes
and Abrasions.

2 fl. oz. (59.1 ml)

Reorder no. 3501

Principal Display Panel – 2 fl. oz Packet Label
ANTISEPTIC 
benzalkonium chloride, benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-5300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1 g  in 1 L
benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine46 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
isopropyl alcohol (UNII: ND2M416302)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-5300-00.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/25/2022
Labeler - Provision Medical (036936831)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(69103-5300)

Revised: 11/2013
Document Id: 7a4c6b17-2bb0-40e8-a855-4c88c7acae49
Set id: 0f6d3ee2-9106-43f9-957a-c1cce4c38ad1
Version: 1
Effective Time: 20131111
 
Provision Medical