FDA.reportPublic FDA data

SterileMAX HAND SANITIZER

Manufacturer
Pure-chem, Llc
Effective date
2020-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:32:23

Label at a glance#

ProductSterileMAX HAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

• Place enough product on hands to cover all surfaces. Rub hands together until dry. • Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

• Store between 15-30C (59-86F) • Avoid freezing and excessive heat above 40C (104F) • Store in a well ventilated place

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 68% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age

• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

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

Other information

STORAGE AND HANDLING SECTION

• Store between 15-30C (59-86F)

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

• Store in a well ventilated place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates, Benzophenone, Carbomer, Vitamin E, Denatonium Benzoate, Water, Glycerin, Fragrance, Diisopropylamine

SPL UNCLASSIFIED SECTION

LEMON CITRUS FRAGRANCE

REFRESHING GEL-BASED FORMULA

MADE IN USA

DANGER: Highly Flammable liquid and vapor. Causes serious eye irritation. Keep container tightly closed. Keep out of reach of children. Keep away from heat/sparks/open flames/hot surfaces. No smoking. Use only non-sparking tools. Take precautionary measures against static discharge. May discolor certain fabrics or surfaces.

IN CASE OF FIRE: Use dry sand, dry chemical or alcohol-resistant foam to extinguish.

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

See SDS for Additional Information.

Distributed By:

Pure-Chem LLC

www.Pure-Chem.com

Manufactured in St. Louis, MO

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Steril1Steril1

100 Pouches100 Pouches

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037039ethanol 68 % Topical GelPSN2
1037039ethanol 0.68 ML/ML Topical GelSCD2
1037039ethanol 68 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79325-862-002022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-012022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-022022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-032022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-042022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-082022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-102022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-122022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-152022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-162022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-202022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-252022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-302022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-322022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER
79325-862-642022-01-28C16284748780-1d6a99b39-b2fa-a426-e053-dadaa90af4c2STERILEMAX HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79325-862-00SterileMAX HAND SANITIZER3785 mL in 1 JUGGEL37852
79325-862-01SterileMAX HAND SANITIZER1 mL in 1 POUCHGEL12
79325-862-02SterileMAX HAND SANITIZER59 mL in 1 BOTTLEGEL592
79325-862-03SterileMAX HAND SANITIZER89 mL in 1 BOTTLEGEL892
79325-862-04SterileMAX HAND SANITIZER100 in 1 CONTAINERGEL1002
79325-862-08SterileMAX HAND SANITIZER237 mL in 1 BOTTLEGEL2372
79325-862-10SterileMAX HAND SANITIZER296 mL in 1 BOTTLEGEL2962
79325-862-12SterileMAX HAND SANITIZER355 mL in 1 BOTTLEGEL3552
79325-862-15SterileMAX HAND SANITIZER1.5 mL in 1 POUCHGEL1.52
79325-862-16SterileMAX HAND SANITIZER473 mL in 1 BOTTLEGEL4732
79325-862-20SterileMAX HAND SANITIZER2 mL in 1 POUCHGEL22
79325-862-25SterileMAX HAND SANITIZER2.5 mL in 1 POUCHGEL2.52
79325-862-30SterileMAX HAND SANITIZER3 mL in 1 POUCHGEL32
79325-862-32SterileMAX HAND SANITIZER946 mL in 1 BOTTLEGEL9462
79325-862-64SterileMAX HAND SANITIZER1892 mL in 1 BOTTLEGEL18922

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79325-862STERILEMAX HAND SANITIZER (ALCOHOL) GEL [PURE-CHEM, LLC]2Legacy NDC, 15 package rows20201024_f1bf45b0-3b75-4925-a654-5f2e72cd2c98.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79325-86279325-862-01, 79325-862-15, 79325-862-04, 79325-862-20, 79325-862-25, 79325-862-30, 79325-862-02, 79325-862-03, 79325-862-08, 79325-862-10, 79325-862-12, 79325-862-16, 79325-862-32, 79325-862-64, 79325-862-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
BENZOPHENONE701M4TTV9OIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DIISOPROPYLAMINEBR9JLI40NOIACT

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
ba579424-6984-4f7c-97dc-a1cebefa37acf1bf45b0-3b75-4925-a654-5f2e72cd2c982020-10-22WarningsExact identifier
spl id: ba579424-6984-4f7c-97dc-a1cebefa37ac
spl set id: f1bf45b0-3b75-4925-a654-5f2e72cd2c98

Reported adverse events (FAERS/openFDA)#

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