Label: BACTEX ANTISEPTIC HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 2, 2009

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient                                Purpose

    Ethyl Alcohol 62 percent                  Antimicrobial

  • PURPOSE

    Uses for hand washing 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 the reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    Wet hands thoroughly with product and allow to dry without wiping.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Deionized water, Propylene Glycol, Glycerol Ethoxylate, Triethanolamine

  • QUESTIONS

    Questions or Comments

    Call: 506 2442 04848

    Write to: Departamento de Mercadeo

    Apartado 344-4050 Alajuela, Costa Rica

    www.puntorojo.com

    Email: informacion@puntorojo.com

  • DESCRIPTION

    Manufactured By:

    Punto Rojo S.A.

    200 Metros Norte de

    los Tribunales de Justicia

    Alajuela, 160-4050

    Costa Rica

  • PRINCIPAL DISPLAY PANEL


    BACTEX
    Antibacterial

    Antiseptic
    Hand Sanitizer

    NO WATER REQUIRED 
    FAST ACTING

    Product Of Costa Rica

    Kills 99.9 percent of Germs

    Net Contents 2.7 Oz.
  • QUESTIONS

    BactexHandSanitizer
  • INGREDIENTS AND APPEARANCE
    BACTEX ANTISEPTIC HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49839-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49839-200-1080 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33311/01/2009
    Labeler - Punto Rojo, S.A (853018687)
    Registrant - Punto Rojo, S.A (853018687)
    Establishment
    NameAddressID/FEIBusiness Operations
    Punto Rojo, S.A853018687manufacture
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