FDA.reportPublic FDA data

Hanzol

Manufacturer
Plymouth Technology, Inc
Effective date
2020-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:18

Label at a glance#

ProductHanzol Liquid Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

hand sanitizer to decrease bacteria on the skin recommended for repeated use for use when soap and water are not available

Dosage and administration

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

Storage and handling

store between 15-30˚C (59-86˚F) avoid freezing and excessive heat above 40˚C (104˚F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 80% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • hand sanitizer to decrease bacteria on the skin
  • recommended for repeated use
  • for use when soap and water are not available

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • store between 15-30˚C (59-86˚F)
  • avoid freezing and excessive heat above 40˚C (104˚F)

INACTIVE INGREDIENT SECTION

Inactive ingredients fragrance, glycerin, hydrogen peroxide, water

SPL UNCLASSIFIED SECTION

Alcohol Antiseptic 80%

Topical Solution

Non-Sterile Solution

DOT CLASSIFICATION

UN1993, Flammable liquid, n.o.s.(ethanol), 3, PGIII

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.

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

www.ptiwater.com

EMERGENCY TELEPHONE NO.

INFOTRAC (800) 535-5053

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76917-080-012022-01-28C16284748780-1d6a99b39-8d28-a426-e053-dadaa90af4c2Hanzol ANTISEPTIC HAND SANITIZER LIQUID
76917-080-052022-01-28C16284748780-1d6a99b39-8d28-a426-e053-dadaa90af4c2Hanzol ANTISEPTIC HAND SANITIZER LIQUID
76917-080-552022-01-28C16284748780-1d6a99b39-8d28-a426-e053-dadaa90af4c2Hanzol ANTISEPTIC HAND SANITIZER LIQUID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76917-080-01Hanzol Liquid Hand Sanitizer3.8 L in 1 CONTAINERLIQUID3.81
76917-080-05Hanzol Liquid Hand Sanitizer18.9 L in 1 CONTAINERLIQUID18.91
76917-080-55Hanzol Liquid Hand Sanitizer208.2 L in 1 DRUMLIQUID208.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76917-080HANZOL LIQUID HAND SANITIZER (ETHYL ALCOHOL) LIQUID [PLYMOUTH TECHNOLOGY, INC]1Legacy NDC, 3 package rows20200523_a1e0354a-d60b-49a1-9b66-a9d021156cdc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76917-08076917-080-01, 76917-080-05, 76917-080-55

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a6808b7b-ff00-42e6-a167-51e670d70859a1e0354a-d60b-49a1-9b66-a9d021156cdc2020-05-06WarningsExact identifier
spl id: a6808b7b-ff00-42e6-a167-51e670d70859
spl set id: a1e0354a-d60b-49a1-9b66-a9d021156cdc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.