Label: ALPHA E-3 INSTANT HAND SANITIZER- ethanol spray

  • NDC Code(s): 69335-002-01
  • Packager: Alpha Chemical Services, Inc.
  • 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 January 28, 2020

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

  • Active Ingredient

    Ethanol 71.0%                

  • Purpose

    Hand Sanitizer

  • Uses

    • Sanitize hands to help reduce bacteria that potentially can cause disease
    • Helps to prevent cross contamination
    • Recommended for repeated use
    • Helps to prevent drying of the skin
  • Warnings

    • For external use only
    • Flammable, keep away from fire or flame
  • When using this product

    • Do not use in or near eyes
    • For external use only
    • Discontinue use if irritation and redness develop
  • Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Directons

    • Wet hands thoroughly with spray, covering entire surface of hands, especially the fingernails and cuticles
    • Rub hands together until dry
  • Other information

    • Store in a cool, dry place below 104° F
  • Inactive ingredients

    water, isopropanol, glycerin, glycerol monolaurate

  • Questions?

    Contact  Alpha Chemical Mon-Fri 9am - 4p PST at 800-464-9872

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Alpha Chemical Services, Inc.

    46 Morton St.

    Stoughton, MA 02072

    www.alphachemical.com

    SDS-18-15002

  • Principal Display Panel

    NDC: 69335-002-01

    Alpha E-3 Instant Hand Sanitizer Spray

    NSF

    Nonfood Compounds Program Listed (E2) Registration #

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ALPHA E-3 INSTANT HAND SANITIZER 
    ethanol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69335-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL710 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69335-002-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/04/2014
    Labeler - Alpha Chemical Services, Inc. (051782316)
    Registrant - Best Sanitizers, Inc (627278224)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers, Inc627278224manufacture(69335-002)