FIRST AID- benzalkonium chloride and benzocaine spray
HART Health

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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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50332-0212
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM)	BENZALKONIUM CHLORIDE	1 mg in 1000 mg
BENZOCAINE (BENZOCAINE)	BENZOCAINE	50 mg in 1000 mg

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL
WATER

Packaging
#	Item Code	Package Description
1	NDC:50332-0212-1	60 mg in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333A	02/06/1996

Labeler - HART Health (069560969)

Revised: 02/2013

Document Id: 2dd9c749-a510-4b9e-acdf-0f34c5239ee9

Set id: a6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a

Version: 1

Effective Time: 20130211

HART Health