NORTH FIRST AID ANTISEPTIC  - benzalkonium chloride, benzocaine spray 
North Safety Products

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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North First Aid Antiseptic Spray

Benzethonium chloride 0.02% w/w

Benzocaine 10% w/w

Purpose

Topical antiseptic

Topical anesthetic

Uses

for temporary relief of pain and itching and helps protect against infection in:

Warnings

For external use only

Flammable

Do not use

  • in or near the eyes or other mucus membranes
  • in case of serious burns
  • in case of deep or puncture wounds
  • for prolonged period of time
  • on large portion of the body

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • condition clears up and recurs within a few days
  • redness, swelling or irritation occurs

Keep out of the reach of children

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

Directions

Other information

Inactive ingredients

dipropylene glycol, isobutane, n-butane, propane

Principal Display Panel

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NORTH FIRST AID ANTISEPTIC  
benzalkonium chloride, benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ISOBUTANE (UNII: BXR49TP611)  
BUTANE (UNII: 6LV4FOR43R)  
PROPANE (UNII: T75W9911L6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0015-4085 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2013
Labeler - North Safety Products (019777263)
Establishment
NameAddressID/FEIBusiness Operations
North Safety Products019777263manufacture(0498-0015)
Establishment
NameAddressID/FEIBusiness Operations
Dixon Investments115315822manufacture(0498-0015)

Revised: 4/2013
Document Id: 4a402e6c-8fae-479e-962f-6a4922fa2a81
Set id: 109e0046-eb93-445b-a224-af897a5a0793
Version: 3
Effective Time: 20130406
 
North Safety Products