FDA.reportPublic FDA data

Polar Pure Hand Sanitizer

Manufacturer
11569635 Canada Inc
Effective date
2020-10-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:12

Label at a glance#

ProductPolar Pure Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product in your palm to thoroughly cover your hands. Rub hands briskly until dry. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

PURPOSE:

OTC - PURPOSE SECTION

Antimicrobial

USE:

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin that could cause disease.Recommended for repeated use.

WARNINGS:

WARNINGS SECTION

Flammable, keep away from fire or flame. For external use only.

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash appears and lasts.

Keep out of reach of children, 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed get medical help or contact a poison control center right away

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Place enough product in your palm to thoroughly cover your hands. Rub hands briskly until dry. Children under 6 years of age should be supervised when using this product.

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

Store below 43 C (110 F). May discolor certain fabrics or surfaces.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Carbomer, Triethanolamine

QUESTIONS?

OTC - QUESTIONS SECTION

1-800-772-5513

Package Labeling:59ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label -59MLLabel -59ML

Package Labeling:236ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label -236MLLabel -236ML

Package Labeling:500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label -500MLLabel -500ML

Package Labeling:1000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label -1LLabel -1L

Package Labeling:4000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 4Llabel 4L

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80608-000-012022-01-28C16284748780-1d6a99b39-e39c-a426-e053-dadaa90af4c2Polar Pure Hand Sanitizer
80608-000-022022-01-28C16284748780-1d6a99b39-e39c-a426-e053-dadaa90af4c2Polar Pure Hand Sanitizer
80608-000-032022-01-28C16284748780-1d6a99b39-e39c-a426-e053-dadaa90af4c2Polar Pure Hand Sanitizer
80608-000-042022-01-28C16284748780-1d6a99b39-e39c-a426-e053-dadaa90af4c2Polar Pure Hand Sanitizer
80608-000-052022-01-28C16284748780-1d6a99b39-e39c-a426-e053-dadaa90af4c2Polar Pure Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80608-000-01Polar Pure Hand Sanitizer59 mL in 1 BOTTLELIQUID591
80608-000-02Polar Pure Hand Sanitizer236 mL in 1 BOTTLELIQUID2361
80608-000-03Polar Pure Hand Sanitizer500 mL in 1 BOTTLELIQUID5001
80608-000-04Polar Pure Hand Sanitizer1000 mL in 1 BOTTLELIQUID10001
80608-000-05Polar Pure Hand Sanitizer4000 mL in 1 BOTTLELIQUID40001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80608-000POLAR PURE HAND SANITIZER (ALCOHOL) LIQUID [11569635 CANADA INC]1Legacy NDC, 5 package rows20201022_b17a0658-04b7-5d88-e053-2a95a90ae0b4.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
80608-00080608-000-01, 80608-000-02, 80608-000-03, 80608-000-04, 80608-000-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB

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
b17a0c22-6e10-6335-e053-2a95a90a6aa8b17a0658-04b7-5d88-e053-2a95a90ae0b42020-10-12WarningsExact identifier
spl id: b17a0c22-6e10-6335-e053-2a95a90a6aa8
spl set id: b17a0658-04b7-5d88-e053-2a95a90ae0b4

Reported adverse events (FAERS/openFDA)#

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