ANTISEPTIC- benzalkonium chloride, benzocaine spray

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by Wildman Business Group, Safetec of America 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 ifcondition persists or gets worse

Directions

• clean affected 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

NDC: 61010-5300-0

Safetec

Cut & Scrape
Antiseptic Spray

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

2 fl. oz. (59.1ml)
Reorder no. 53000

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
benzalkonium chloride, benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84269-3501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	50 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 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: 84269-3501-1	60 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	09/01/2024

Labeler - Wildman Business Group (016677338)

Registrant - Safetec of America Inc (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	manufacture(84269-3501)