Label: DUKAL STERILE ALCOHOL SWABSTICK- isopropyl alcohol swab

  • NDC Code(s): 65517-2022-1, 65517-2022-3
  • Packager: Dukal Corporation
  • 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 October 3, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients

    Isopropyl Alcohol 70%

    Purpose

    Antiseptic

  • PURPOSE

    Use

    For Preparation of Skin prior to an injection

  • INDICATIONS & USAGE

    Wipe injection site vigorously and discard

  • WARNINGS

    Warnings

    • For External Use Only
    • Flammable, Keep away from fire or flame
  • DO NOT USE

    Do Not Use

    • with electrocautery procedures
    • In the Eyes. If contact occurs, flush eyes with water
  • STOP USE

    Stop Use

    If irritation and redness develop. If condition persists, consult your health care practitioner.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • DOSAGE & ADMINISTRATION

    Other Information

    Store at Room Temperature 15 - 30 C (59 - 86 F)

  • STORAGE AND HANDLING

    Other Information

    Store at Room Temperature 15 - 30 C (59 - 86 F)


  • INACTIVE INGREDIENT

    Inactive Ingredient

    purified water

  • PRINCIPAL DISPLAY PANEL

    1 per pouch

    Dukal Corporation

    Ref 887

    NDC 65517-2022-1

    Sterile

    ALCOHOL

    SWABSTICKS

    Saturated with 70% Isopropyl Alcohol

    For External Use Only

    Sterility guaranteed unless package is damaged or opened.

    1 / Pouch Latex 2

    Manufactured For:

    Dukal Corporation 631-656-3800

    Ronkonkoma, NY 11779 www.dukal.com

    Made in China

  • PRINCIPAL DISPLAY PANEL

    3 per pouchDukal Corporation

    Ref 892

    NDC 65517-2022-3

    Sterile

    ALCOHOL

    SWABSTICKS

    Saturated with 70% Isopropyl Alcohol

    For External Use Only

    Sterility guaranteed unless package is damaged or opened.

    3 / Pouch Latex 2

    Manufactured For:

    Dukal Corporation 631-656-3800

    Ronkonkoma, NY 11779 www.dukal.com

    Made in China

  • INGREDIENTS AND APPEARANCE
    DUKAL STERILE ALCOHOL SWABSTICK 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-2022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65517-2022-13 mL in 1 POUCH; Type 0: Not a Combination Product07/22/2019
    2NDC:65517-2022-36.5 mL in 1 POUCH; Type 0: Not a Combination Product07/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2000
    Labeler - Dukal Corporation (791014871)