ANTISEPTIC- benzalkonium chloride, benzocaine spray

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by JHK Inc, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

Purpose

First aid antiseptic

Topical pain relief

Uses

First aid to help prevent infection and relieve pain 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 conditions persist or get worse.

Directions

• clean the affected area
• apply a small amount of this product on the area 1 - 3 times daily
• children under 2 ask a doctor

Other Information

• store at room temperature

Inactive ingredients

isopropyl alcohol, purified water

Questions?

1-866-651-3660

Mon-Fri 8:00am-5:00pm EST

Manufactured for American Safety & First Aid Osceola, IN 48561

V1_11-7-19

Principal Display Panel – Bottle Label

0681

NDC: 73598-0681-1

Antiseptic

First Aid Antiseptic

For Temporary Pain Relief
and to Help Prevent
Infection in Minor Cuts,
Scrapes and Abrasions

American Safety
& First Aid

2 fl. Oz. (59.1 ml)

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
benzalkonium chloride, benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73598-0681
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y)	benzalkonium chloride	100 mg  in 1 mL
benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5)	benzocaine	50 mg  in 1 mL

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: 73598-0681-1	59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/14/2020

Labeler - JHK Inc (867236309)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(73598-0681)