ANTISEPTIC FIRST AID- benzalkonium chloride and benzocaine spray

Antiseptic First Aid by

Drug Labeling and Warnings

Antiseptic First Aid by is a Otc medication manufactured, distributed, or labeled by Acme United Corp, Safetec of America, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 a doctor if condition persists or gets worse

Directions

• clean affected area
• spray over the area 1 to 3 times daily
• may be covered with a sterile bandage
• children under 2 ask a doctor

Inactive ingredients

isopropyl alcohol, purified water

Questions?

call 203-857-5361

Principal Display Panel - Bottle Label

13-080

ANTISEPTICS

FIRST AID ONLY®

Antiseptic
First Aid Spray

Antiseptic first aid spray
with pain reliever for use
on minor cuts, scrapes
and burns

4 fl oz (118.3ml)

INGREDIENTS AND APPEARANCE

ANTISEPTIC FIRST AID 
benzalkonium chloride and benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0931
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y)	benzalkonium chloride	1 mg  in 1 g
benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5)	benzocaine	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
isopropyl alcohol (UNII: ND2M416302)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0931-01	107 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/06/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/06/2014

Labeler - Acme United Corp (001180207)

Registrant - Safetec of America, Inc (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc		874965262	MANUFACTURE(0924-0931)