I.V. PREP ANTISEPTIC WIPE (ISOPROPYL ALCOHOL) SOLUTION [SMITH & NEPHEW, MEDICAL LTD]

I.V. PREP ANTISEPTIC WIPE (ISOPROPYL ALCOHOL) SOLUTION [SMITH & NEPHEW, MEDICAL LTD]
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NDC 69740-212-00
Set ID 50f1c74a-bb8e-41c2-a7ee-f2d310a372a7
Category HUMAN OTC DRUG LABEL
Packager Smith & Nephew, Medical Ltd
Generic Name
Product Class
Product Number
Application Number PART333A
  • DRUG FACTS
  • ACTIVE INGREDIENTS (IN EACH PACKET)

     Isopropyl Alcohol 70% v/v

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  • PURPOSE

    Antiseptic

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  • USES

    For preparation of the skin prior to injection or venipuncture

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  • WARNINGS

    • FLAMMABLE Use in a well ventilated area and avoid using near flames or sources of ignition (i.e. electrocautery procedures).
    • Sterile
    • For external use only
    • Do not use in or near the eyes
    • Discontinue use if irritation or redness develops
    • If condition persists more than 72 hours, consult a physician
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  • KEEP OUT OF REACH OF CHILDREN

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

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  • DIRECTIONS

    • clean the area
    • start at the venipuncture site and apply in a circular fashion using friction
    • Allow to thoroughly air dry
    • Repeat with a new wipe as necessary to cover sufficient area
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  • INACTIVE INGREDIENTS

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

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  • QUESTIONS

    Made in the USA for Smith & Nephew Medical Ltd

    101 Hessle Road, Hull, HU3 2BN, England

    Customer Care Centre: 1 800 876 1261

    www.smith-nephew.com

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  • PRINCIPAL DISPLAY PANEL

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

    #59421200

    NDC 69740-212-00

    I.V. PREP

    Antiseptic Wipes

    • for preparation of the skin prior to injection or venipuncture
    • contains 70% IPA

    50 Wipes

    50 wipes

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- 1 Packet

    #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

    1 Wipe

     Made in the USA for Smith & Nephew Medical Ltd

    101 Hessle Road, Hull, HU3 2BN, England

    Customer Care Centre: 1 800 876 1261

    www.smith-nephew.com

    1 Wipe

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  • INGREDIENTS AND APPEARANCE
    I.V. PREP ANTISEPTIC WIPE 
    isopropyl alcohol solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69740-212
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.57 
    Inactive Ingredients
    Ingredient Name Strength
    ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ) 0.0042 
    WATER (UNII: 059QF0KO0R) 0.2833 
    TRICLOSAN (UNII: 4NM5039Y5X) 0.0025 
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69740-212-00 50 in 1 BOX 10/01/1999
    1 1 in 1.0 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 10/01/1999
    Labeler - Smith & Nephew, Medical Ltd (216344051)
    Establishment
    Name Address ID/FEI Business Operations
    Span Packaging Solutions 557434805 MANUFACTURE(69740-212)
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