Label: HANZOL GELLED HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 22, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin

    • recommended for repeated use

    • for use when soap and water are not available

  • Warnings

    Flammable, keep away from fire/flame 

    For external use only

    Do not use

    • in children less than 2 months of age

    • on open skin wounds

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • irritation and redness develop

    • condition persists for more than 72 hours 

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping

    • supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • store between 15-30° C (59-86° F) 

    • avoid freezing and excessive heat above 40° C (104°F)

  • INACTIVE INGREDIENT

    Inactive ingredients  carbomer, fragrance, glycerin, hydrogen peroxide, sodium hydroxide, water

  • QUESTIONS

    Questions? 1-248-537-0081

    You may also report serious side effects to this phone number.

    Mon- Fri 9:00AM - 5.00PM

  • SPL UNCLASSIFIED SECTION

    Alcohol Antiseptic 70%

    Topical Solution

    Non-Sterile Solution

    FLAMMABLE LIQUID

    Ground/bond container and receiving equipment.

    Use explosion-proof electrical/ventilating/light/equipment.

    Use only non-sparking tools.

    Take precautionary measures against static discharge.

    Do not breathe dust/fume/gas/mist/vapors/spray.

    Avoid breathing dust/fume/gas/mist/vapors/spray.

    Wash face,hands, and any exposed skin thoroughly after handling.

    Do not eat, drink or smoke when using this product.

    Use only outdoors or in a well-ventilated area.

    Wear protective gloves/protective clothing/eye protection/face protection

    IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water [or shower].

    IF INHALED:Remove person to fresh air and keep at rest in a position comfortable for breathing.

    Store in a well-ventilated place. Keep container tightly closed.

    Dispose of contents/container in accordance with local/regional/national/international regulations.

    DOT CLASSIFICATION

    UN1170, Flammable liquid, n.o.s.(ethanol), 3, II Lot Number:

    MADE IN USA

    Manufactured by: Plymouth Technology, Inc, 2700 Bond St, Rochester Hills, MI 48309

    EMERGENCY TELEPHONE NO.

    INFOTRAC (800) 535-5053

    www.ptiwater.com

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    HANZOL  GELLED HAND SANITIZER
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76917-074
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76917-074-013.8 L in 1 JUG; Type 0: Not a Combination Product05/11/2020
    2NDC:76917-074-0518.9 L in 1 CONTAINER; Type 0: Not a Combination Product05/11/2020
    3NDC:76917-074-55208.2 L in 1 DRUM; Type 0: Not a Combination Product05/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/11/2020
    Labeler - Plymouth Technology, Inc. (555926443)
    Establishment
    NameAddressID/FEIBusiness Operations
    Plymouth Technology, Inc.555926443manufacture(76917-074)