Label: ALCOHOL- isopropyl alcohol swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 28, 2016

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  • DOSAGE & ADMINISTRATION

    Two swabsticks saturated with 70% isopropyl alcohol.


    Apply swabstick to skin.


  • INACTIVE INGREDIENT

    water

  • INDICATIONS & USAGE

    To clean injection and other catheter sites.

    Apply swabstick to skin.

  • KEEP OUT OF REACH OF CHILDREN

    <Hospital professional use>

  • WARNINGS

    For external use only

    Discard after single use


  • PURPOSE

    <To clean injection and other catheter sites.>


  • ACTIVE INGREDIENT

    isopropyl alcohol 70 %

  • PRINCIPAL DISPLAY PANEL

    Alcohol Swab 3-pc FrontAlcohol Swab 3-pc backAlcohol Swab FrontAlcohol Swab Back<alcohol swabsticks saturated with 70% isopropyl alcohol, for professional and hosptial use>

  • INGREDIENTS AND APPEARANCE
    ALCOHOL 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49953-2801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL7 mL  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49953-2801-21 mL in 1 POUCH; Type 0: Not a Combination Product07/02/2010
    2NDC:49953-2801-33 mL in 1 POUCH; Type 0: Not a Combination Product07/02/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34407/02/2010
    Labeler - Dalian Rongbang Medical Healthy Devices Co., Ltd. (529882730)
    Registrant - Dalian Rongbang Medical Healthy Devices Co., Ltd. (529882730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Rongbang Medical Healthy Devices Co., Ltd.529882730manufacture(49953-2801)
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