ANTISEPTIC- benzalkonium chloride, benzocaine spray

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by Afassco Inc., 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 doctor if condition persists or gets worse

Directions

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

Inactive ingredients

isopropyl alcohol, purified water

PRINCIPAL DISPLAY PANEL – bottle label

First Aid
Antiseptic
Spray

Aids in Preventing Infections

Temporary Pain Relief
Fights Infection
Promotes Healing

#623 2 Fl. Oz. (59 mL)

Mfd. For
Afassco
MINDEN, NV 89423

res

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
benzalkonium chloride, benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51532-5300
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 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: 51532-5300-3	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/09/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/09/2012

Labeler - Afassco Inc. (609982723)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(51532-5300)