FIRST AID ANTISEPTIC- benzalkonium chloride and 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

Benzaikonium 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 - Bottle Label

first aid
ANTISEPTIC
SPRAY

Treats Minor Cuts, Scrapes and Burns
Helps Prevent Infection and Relieves Pain

Package Not Child Resistant

2 fl. oz. (59.15ml)

Manufactured for

Provision Medical Products Palm Desert, CA 92211

Figure
FIRST AID ANTISEPTIC 
benzalkonium chloride and benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-3501
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) benzocaine50 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
isopropyl alcohol (UNII: ND2M416302)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-3501-10.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/29/2014
Labeler - Provision Medical (036936831)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(69103-3501)

Revised: 8/2014
Document Id: ed3cb7fd-75d1-4b20-ad45-39fd5763a751
Set id: 527232df-20d6-4e10-a478-e42a7a6dc20f
Version: 1
Effective Time: 20140829
 
Provision Medical