Label: I.V. PREP ANTISEPTIC WIPE- isopropyl alcohol solution

  • 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 April 23, 2021

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  • DRUG FACTS

  • ACTIVE INGREDIENTS (IN EACH PACKET)

     Isopropyl Alcohol 70% v/v

  • PURPOSE

    Antiseptic

  • USES

    For preparation of skin prior to injection or venipuncture

  • WARNINGS

    • FLAMMABLE Use in a well-ventilated area and avoid using near flames or sources of ignition i.e. electrocautery procedures
    • Sterile. Do not use if pack is open or damaged
    • For external use only.Do not use in or near the eyes
    • Discontinue use if irritation or redness develop. If condition persists more than 72 hours, consult a physician
    • Limit exposure only to the immediate application site. Avoid use on children less than 12 years old as it may lead to irritation
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poisin Control Center immediately

  • DIRECTIONS

    • clean the area
    • start at the venipuncture site and apply in a circular fashion using friction
    • Let dry and repeat procedure
    • Allow I.V. PREP to dry prior to application of dressings
  • CONTRAINDICATION

    Should not be used on full-term or premature babies less than 1 month

  • INACTIVE INGREDIENTS

    acetyl tributyl citrate, butyl ester of PVM/MA copolymer, benzalkonium chloride, water

  • QUESTIONS

    Made in the USA for Smith & Nephew Medical Ltd

    101 Hessle Road, Hull, HU3 2BN, England

    Customer Care Center: 1 800 876-1261

    www.smith-nephew.com

  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- BOX OF 50 WIPES (Front)

    #59421200

    NDC 69740-212-00

    I.V. PREP

    (isopropyl alcohol, 70%)

    Antiseptic Wipes

    Sterile Solution

    • For preparation of the skin prior to injection or venipuncture

    50 Wipes

    50 wipes

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- 1 Packet

    #59421200

    NDC 69740-212-00

    I.V. PREP

    (isopropyl alcohol, 70%)

    Antiseptic Wipe

    Sterile Solution

    •  For preparation of the skin prior to injection or venipuncture

    1 Wipe

     Made in the USA for Smith & Nephew Medical Ltd

    101 Hessle Road, Hull, HU3 2BN, England

    Customer Care Center: 1 800 876-1261

    www.smith-nephew.com

    1 Wipe

  • INGREDIENTS AND APPEARANCE
    I.V. PREP ANTISEPTIC WIPE 
    isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.57 
    Inactive Ingredients
    Ingredient NameStrength
    ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69740-212-0050 in 1 BOX10/01/1999
    11 in 1.0 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/1999
    Labeler - Smith & Nephew, Medical Ltd (216344051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Span Packaging Solutions557434805MANUFACTURE(69740-212)