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Antiseptic by Safetec of America

Medically reviewed on June 11, 2018

Dosage form: liquid
Ingredients: isopropyl alcohol 715mL in 1L
Labeler: Safetec of America
NDC Code: 61010-7000

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.

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

ANTISEPTIC 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-7000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
isopropyl alcohol (isopropyl alcohol) isopropyl alcohol715 mL  in 1 L
Inactive Ingredients
Ingredient NameStrength
water 
alcohol 
acetyltributyl citrate 
chloroxylenol 
Packaging
#Item CodePackage Description
1NDC:61010-7000-150 PACKET (50 PACKET) in 1 BOX
1NDC:61010-7000-00.0012 L in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/02/2011
Labeler - Safetec of America (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE

 
Safetec of America

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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