ANTISEPTIC- isopropyl alcohol liquid

Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Isopropyl Alcohol 71.5%

Purpose

Antiseptic

Uses

• For preparation of the skin prior to injection or venipuncture

Warnings

For external use only

Flammable. Keep away from fire or flame

Do not use with electrocautery procedures or in or near the eyes. If this happens, rinse thoroughly with water.

Stop use and ask doctor if irritation or redness develop and persists for more than 72 hours

Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away

Directions

• start at the venipuncture site and apply in a circular fashion
• use additional wipes as necessary to cover area

Inactive ingredients

purified/deionized water, ethyl ester of PVMA/MA copolymer, ethyl alcohol, acetyl tributyl citrate, chloroxylenol

PRINCIPAL DISPLAY PANEL – packet label

Safetec

I.V. Prep

Antiseptic/Barrier Wipe

For preparation of the skin prior to injection or venipuncture

Contents: 1 single-use, premoistened towelette

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

PRINCIPAL DISPLAY PANEL – box

Safetec

Contents: 50 individual, single-use, premoistened towelettes

NDC: 61010-7000-1

I.V. Prep

Antiseptic/Barrier Wipe

For preparation of the skin prior to injection or venipuncture

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-7000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
isopropyl alcohol (UNII: ND2M416302) (isopropyl alcohol - UNII:ND2M416302)	isopropyl alcohol	715 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
alcohol (UNII: 3K9958V90M)
acetyltributyl citrate (UNII: 0ZBX0N59RZ)
chloroxylenol (UNII: 0F32U78V2Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-7000-1	50 in 1 BOX
1	NDC: 61010-7000-0	0.0012 L in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/02/2011

Labeler - Safetec of America (874965262)

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