BENZOCAINE AND BENZETHONIUM- benzocaine and benzethonium aerosol, spray 
Tender Corporation

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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Genuine First Aid Antiseptic Spray

Active Ingredients

Benzethonium Chloride 0.2% w/w

Benzocaine 10% w/w

Purpose

Topical Antiseptic

Topical Anesthetic

Uses

For temporary relief of pain, treatment and helps prevent infection in

Warnings

For external use only

Flammable:

  • keep away from fire or flame
  • contents under pressure
  • do not puncture or incinerate container
  • do not expose to temperatures above 120°F

Do not use:

  • in or near mucous membranes
  • on serious burns
  • on deep puncture wounds
  • for a prolonged period of time
  • on a large portion of the body

Stop use and ask a doctor if:

  • redness, swelling, or irritation occurs
  • infection occurs
  • condition persists or worsens
  • symptoms persists for more than 7 days

Keep out of 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

Label

Label

BENZOCAINE AND BENZETHONIUM 
benzocaine and benzethonium aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-3120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE170 mg  in 85 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE8500 mg  in 85 g
Inactive Ingredients
Ingredient NameStrength
PROPANE (UNII: T75W9911L6)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ISOBUTANE (UNII: BXR49TP611)  
BUTANE (UNII: 6LV4FOR43R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44224-3120-185 g in 1 CAN; Type 0: Not a Combination Product08/19/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/19/2014
Labeler - Tender Corporation (064437304)

Revised: 6/2016
Document Id: 35ce2638-6a78-41dd-e054-00144ff8d46c
Set id: 35ce2638-6a77-41dd-e054-00144ff8d46c
Version: 1
Effective Time: 20160621
 
Tender Corporation