Label: ALPHA BAC STOP E-2- chloroxylenol solution

  • NDC Code(s): 69335-001-01
  • 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

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  • Active Ingredient

    Chloroxylenol (1.50% w/w)  

  • Purpose

    Antiseptic Hand Cleanser

  • Uses

    • Handwash to help reduce bacteria that potentially can cause diseases
    • Helps to prevent cross contamination by hand contact
    • Helps to prevent drying of the skin
    • Recommended for repated use
  • Warnings

    • For external use only
  • When using this product

    • Do not use in or near eyes
  • Keep out of reach of children

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

  • Directons

    • Wet hands and forearms
    • Apply an application to hands and forearms
    • Scrub thoroughly for at least 30 seconds (include the fingernails and the cuticles)
    • Rinse
  • Other information

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

    water, sodium laureth sulfate, isopropyl alcohol, phenoxyethanol, glycerine, triclosan, TetraSodium EDTA, citric acid

  • 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: 69335-001-01

    ALPHA BAC STOP E-2

    1.5% PCMX FORMULA

    NSF

    Nonfood Compounds Program Listed (E2) Registration #

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ALPHA BAC STOP E-2 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69335-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69335-001-013785 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 finalpart333A11/04/2014
    Labeler - Alpha Chemical Services, Inc. (051782316)
    Registrant - Best Sanitizers, Inc (627278224)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers, Inc627278224manufacture(69335-001)
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