Label: ANTISEPTIC- isopropyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated June 9, 2011

If you are a consumer or patient please visit this version.

View All Sections
  • 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 – packet label
  • 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

    PRINCIPAL DISPLAY PANEL – box
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-7000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    isopropyl alcohol (UNII: ND2M416302) (isopropyl alcohol - UNII:ND2M416302) isopropyl alcohol715 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    alcohol (UNII: 3K9958V90M)  
    acetyltributyl citrate (UNII: 0ZBX0N59RZ)  
    chloroxylenol (UNII: 0F32U78V2Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-7000-150 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/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!