Your browser does not support JavaScript! FIRST AID (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [HART HEALTH]
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FIRST AID (benzalkonium chloride, benzocaine) spray
[HART Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active Ingredients

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

Purpose

Topical Antiseptic

Topical Anethetic

Uses

First aid to help protect against skin infection and for the temporary relief of pain and itching in

  • minor cuts and scrapes
  • bites
  • skin irritation

Warnings

For external use only.

Flammable, keep away from heat or flame

Do not use

  • in or near the eyes
  • over large portions of the body
  • in large quantities, particularly over raw surfaces or blistered areas
  • on deep or puncture wounds
  • on animal bites
  • on serious burns
  • longer than 7 days unless directed by a doctor

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions

  • 2.2ex0em2.2ex0emclean affected area and spray 1 to 3 times daily
  • 2.2ex0em2.2ex0emmay be covered with a sterile bandage

Children under 2 years of age: ask a doctor

Inactive Ingredients

Isopropyl Alcohol, Purified Water

FirstAidSpray

FIRST AID 
benzalkonium chloride, benzocaine spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50332-0212
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE1 mg  in 1000 mg
BENZOCAINE (BENZOCAINE) BENZOCAINE50 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0212-160 mg in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333A02/06/1996
Labeler - HART Health (069560969)

Revised: 2/2013
 
HART Health

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