FIRST AID ANTISEPTIC- benzalkonium chloride and benzocaine spray

First Aid Antiseptic by

Drug Labeling and Warnings

First Aid Antiseptic by is a Otc medication manufactured, distributed, or labeled by Unishield , 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
• 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

• spray over cleaned affected 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 1-800-480-5855

Principal Display Panel - Bottle Label

UniShield

FIRST AID
ANTISEPTIC
SPRAY

TREATS:

• Minor Cuts
• Scrapes
• Scratches

HELPS:

• Prevent Infection
• Relieve Pain

NET CONTENTS 2 FL. OZ. (59.1 ML)

Distributed by: Unishield, San Francisco, CA 91340

Made in USA

INGREDIENTS AND APPEARANCE

FIRST AID ANTISEPTIC 
benzalkonium chloride and benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49314-0098
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: 49314-0098-1	59 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/27/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/27/2015

Labeler - Unishield (790677053)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc		874965262	MANUFACTURE(49314-0098)