Label: HAND SANITIZER- alcohol solution

  • NDC Code(s): 64942-1743-1, 64942-1743-2, 64942-1743-3, 64942-1743-4
  • Packager: Conopco, Inc. d/b/a/ Unilever
  • 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 May 6, 2021

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient(s)Purpose
    Ethyl Alcohol 72% v/vAntiseptic
  • INDICATIONS & USAGE

    Use(s) Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

  • Warnings

    For external use only

    Flammable. Keep away from heat or flame.

  • Do not use:

    • on children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • ASK DOCTOR

    Discontinue use and ask a doctor if irritation, redness or rash occurs. These may be signs of a serious condition.

  • 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.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry
    • Supervise children under 6 years of age when using this product
  • Other information

    • Store below 105°F (40.5°C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Water, Hydroxypropylcellulose, Glycerin (Vegetable), Pyrus Malus (Apple) Fruit Extract, Shea Butter Ethyl Esters, Argania Spinosa (Argan) Kernel Oil, Boswellia Serrata (Frankincense) Extract, Commiphora Myrrha (Myrrh) Resin Extract, Fragrance

  • PACKAGE LABEL

    KILLS 99.99%
    OF MANY COMMON BACTERIA

    Shea Moisture®
    Established 1912

    HAND
    SANITIZER

    W/ ARGAN OIL &
    PLANT BASED EXTRACTS

    3.2 fl oz / 95 mL

    Distributed by: Sundial Brands, 11 Ranick Drive South, Amityville, NY 11701

    Questions? Call us at 1-866-478-1925

    Empty Before
    Recycling

    PLASTIC
    BOTTLE

    how2recyle.info

    68647784

    PLD Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1743
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Hydroxypropyl Cellulose, Unspecified (UNII: 9XZ8H6N6OH)  
    Glycerin (UNII: PDC6A3C0OX)  
    Apple (UNII: B423VGH5S9)  
    Shea Butter (UNII: K49155WL9Y)  
    Argan Oil (UNII: 4V59G5UW9X)  
    Indian Frankincense (UNII: 4PW41QCO2M)  
    Myrrh (UNII: JC71GJ1F3L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1743-1237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    2NDC:64942-1743-295 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    3NDC:64942-1743-3384 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    4NDC:64942-1743-4946 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/22/2020
    Labeler - Conopco, Inc. d/b/a/ Unilever (001375088)
    Registrant - Apex International MFG, Inc. (015226132)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apex International MFG, Inc.015226132manufacture(64942-1743)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!