ANTISEPTIC- alcohol, benzocaine liquid

Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Ethyl alcohol 50.0%

Benzocaine 6.0%

Purpose

First Aid Antiseptic

Topical Analgesic

Uses

First aid to help prevent infection in minor scrapes and temporary relief of itching of insect bites

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

• over large areas of the body
• in eyes
• over raw or blistered areas

Stop use and ask doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

Directions

Adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily. Children under 2 years of age: Consult a doctor.

Inactive ingredients

benzalkonium chloride, menthol, purified water

PRINCIPAL DISPLAY PANEL – pouch label

NDC: 61010-7200-0

Safetec

Sting Relief
Insect Bite
Antiseptic and Pain Reliever

Contents: 1 single-use, premoistened towelette

Manufactured by SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 800-456-7077 www.safetec.com

EXP. LOT

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
alcohol, benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-7200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)	alcohol	500 mg  in 1 g
benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5)	benzocaine	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
benzalkonium chloride (UNII: F5UM2KM3W7)
menthol (UNII: L7T10EIP3A)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-7200-0	0.8 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/12/2011

Labeler - Safetec of America, Inc. (874965262)

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