Label: INSTANT HAND SANITIZING WIPE- ethyl alcohol swab

  • 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 21, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    Ethyl Alcohol 65.9% by volume

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • For handwashing to decrease bacteria on the skin.
    • For sanitizing hands after assisting ill persons, or Prior to contacting with a person under medical care or treatment
    • Topical Application to skin to help prevent cross-contamination.
  • WARNINGS

    Warnings
    Flammable. Keep away from fire, flame or source of ignition i.e. electrocautery procedures.
    For external use only.

  • STOP USE

    Do not use in or contact with eyes.
    Discontinue use if irritation and redness develop. If condition persists more than 72 hours, consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children unless under adult supervision.
    if swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    To dispense, remove cover, discard seal from container, pull center sheet from roll, twist wipe to a point and thread through dispenser hole in cover.
    Replace cover. Pull out wipe and snap off at 90 degree angle. The next wipe is ready for dispensing. Apply wipe thoroughly onto hands and allow to dry.
    No rinsing required. Discard after single use. Dispose of used wipes in trash receptacle. Do not flush. When not in use, keep lid closed to prevent evaporation.

  • OTHER SAFETY INFORMATION

    Other information
    Lot No. and Expiration Date can be found on canister.
    Store at 53.6 - 93.2*F (12-34*C)

  • INACTIVE INGREDIENT

    Inactive ingredients
    Aminomethyl Propanol, Aloe, Barbadensis Leaft Powder, Carbomer, Glycerin, Propylene Glycol, Tocopheryl Acetate, Water

  • QUESTIONS

    Questions? Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL

    McKesson

    68599-5808-6

    16-3460

    Instant Hand Sanitizing Wipe

    5.5 in x 7.9 in

    (14 cm x 20 cm)

    160 wipes per canister

    16-3460 each

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZING WIPE 
    ethyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-5808
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65.9 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE (UNII: V5VD430YW9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-5808-6160 in 1 BOX; Type 0: Not a Combination Product02/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/24/2020
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    AHC LTD413138557manufacture(68599-5808)
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