FIRST AID ANTISEPTIC- benzalkonium chloride, benzocaine spray 
First Aid Only

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.

----------

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 doctor if condition persists or gets worse

Directions

Inactive ingredients

isopropyl alcohol, purified water

First Aid Antiseptic

Temporary pain relief. Helps prevent infection in minor cuts, scrapes and abrasions.

M5081

3 fl. oz (88.7 ml.)
----------
FIRST AID ONLY

Distributed by First Aid Only, Inc

Vancouver, WA 96882 USA

Principal Display Panel
FIRST AID ANTISEPTIC 
benzalkonium chloride, benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62985-5081
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride0.96 g  in 1 L
benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine58.5 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
isopropyl alcohol (UNII: ND2M416302)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62985-5081-10.0887 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/13/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/13/2014
Labeler - First Aid Only (196551634)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(62985-5081)

Revised: 8/2014
Document Id: ada89565-b9ad-4f6f-a293-275e707c9f9f
Set id: 673646aa-906c-424a-a2f4-07048160c5dc
Version: 2
Effective Time: 20140813
 
First Aid Only