ISOPROPYL ALCOHOL SEPP (ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]

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ISOPROPYL ALCOHOL SEPP (ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]
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NDC 54365-170-01
Set ID 597a86c0-99f3-4df6-be4a-208106a7799a
Category HUMAN OTC DRUG LABEL
Packager CareFusion 213 LLC
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Active ingredient

    Isopropyl alcohol 70% v/v, USP

  • Purpose

    Antiseptic

  • Use

     
    for the preparation of the skin prior to injection.
  • Warnings

    For external use only. Flammable: Keep away from fire or flame

    Do not use with electrocautery procedures

    Do not use

    •
    In the eyes
    •
    on patients with known allergies to isopropyl alcohol

    When using this product

    keep out of eyes, ears, and mouth

    Stop use and ask a doctor if

    irritation, sensitization, or allergic reaction occurs. You may report side effects to FDA at 1-800-FDA-1088.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    1
    remove the applicator wrapper. Do not touch the applicator tip.
    2
    with the applicator tip facing downward, pinch the barrel of the applicator ONCE to release the antiseptic.
    3
    press the applicator tip against the patient’s skin. With gentle back and forth actions apply solution to the treatment area.
    4
    the area covered should be allowed to dry naturally.
    5
    discard after single use
  • Other information

     
    store below 30 °C (86 °F)
  • Inactive ingredients

     
    USP purified water
  • Questions?

    1
    Call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)
  • Package/Label Principal Display Panel

    Carton primary display panel

    IPA Sepp Carton Primary Display Panel

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL SEPP 
    isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54365-170
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL.70 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54365-170-01200 in 1 CARTON
    11 in 1 POUCH
    10.67 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/01/1988
    Labeler - CareFusion 213 LLC (826496312)
    Registrant - CareFusion 2200, Inc (832696038)
    Establishment
    NameAddressID/FEIBusiness Operations
    CareFusion 213 LLC826496312LABEL(54365-170) , MANUFACTURE(54365-170) , PACK(54365-170)
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