Label: ANTISEPTIC- ethanol gel

  • NDC Code(s): 68599-5322-1, 68599-5322-2, 68599-5322-4, 68599-5322-5, view more
    68599-5322-6
  • Packager: McKesson
  • 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 June 4, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients

    Ethanol 62%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use:

    To decrease bacteria on the skin.

  • WARNINGS

    Warnings:

    FLAMMABLE, keep away from fire or flame.

    For external use only.

    • Do not use in the eyes
    • Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.
  • 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

    Directions: Rub into skin until dry.

  • OTHER SAFETY INFORMATION

    Other Information:

    Store below 110F. Avoid direct sunlight, fluorescent lighting, heat, and moisture.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Aloe Barbadensis Leaf Juice, Maltodextrin,
    Glycerin, Propylene Glycol, Fragrance,
    Acrylates/C10-30 Alkyl Acrylate Cross Polymer,
    Triethanolamine

  • QUESTIONS

    Questions:

    Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-5322-1

    McKesson Hand Sanitizer

    With Aloe

    With Moisturizers and Emollients

    For frequent use

    Net Content

    4 fl oz (118mL)

    MFR# 16-1068

    16-1068 each

    NDC 68599-5322-2

    McKesson Hand Sanitizer

    With Aloe

    With Moisturizers and Emollients

    For frequent use

    Net Content

    4 fl oz (118mL)

    24 per case

    Warning: Flammable, keep away from fire or flame

    Store below 110F (43C)

    16-1068 case

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-5322-4

    McKesson Hand Sanitizer

    With Aloe

    With Moisturizers and Emollients with Pump

    For frequent use

    Net Content

    8 fl oz (237mL)

    MFR# 16-1069 16-1069 each

    NDC 68599-5322-5

    McKesson Hand Sanitizer

    With Aloe

    With Moisturizers and Emollients with Pump

    Net Content

    8 fl oz (237mL)

    24 per Case

    MFR# 16-1069

    Warning: Flammable, keep away from fire or flame.

    16-1069 case

  • PRINCIPAL DISPLAY PANEL

    ​NDC 68599-5322-6

    McKesson

    Hand Sanitizers with Aloe

    16.9 fl oz (500mL)

    12 per case

    MFR# 16-1070

    16-1070-each

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-5322
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-5322-224 in 1 CASE02/27/2018
    1NDC:68599-5322-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68599-5322-524 in 1 CASE02/27/2018
    2NDC:68599-5322-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:68599-5322-6500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/27/2018
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc421280161manufacture(68599-5322)
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