ANTISEPTIC - benzalkonium chloride and benzocaine spray
Safetec of America, Inc.

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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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 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

ANTISEPTIC
benzalkonium chloride, benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61010-5300
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzalkonium chloride (benzalkonium)	benzalkonium chloride	1 mL in 1 L
benzocaine (benzocaine)	benzocaine	50 mL in 1 L

Inactive Ingredients
Ingredient Name	Strength
isopropyl alcohol
water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:61010-5300-0	0.0591 L in 1 BOTTLE, SPRAY	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/15/2012

Labeler - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Operations
Safetec of America, Inc.		874965262	MANUFACTURE

Revised: 02/2012 Safetec of America, Inc.