FDA.reportPublic FDA data

HYGIEE Hand sanitizer

Manufacturer
AL SAFI CHEMICALS IND LLC
Effective date
2021-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:50

Label at a glance#

ProductHYGIEE Hand sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

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 at 1-800-222-1222.

Direction

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.

SPL UNCLASSIFIED SECTION

Other information

• Store between 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Product labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81299-001-012022-07-29C16284748780-1e4f33bdf-9c62-d8a0-e053-dadaa90a6e4eHYGIEE
81299-001-022022-07-29C16284748780-1e4f33bdf-9c62-d8a0-e053-dadaa90a6e4eHYGIEE
81299-001-032022-07-29C16284748780-1e4f33bdf-9c62-d8a0-e053-dadaa90a6e4eHYGIEE
81299-001-042022-07-29C16284748780-1e4f33bdf-9c62-d8a0-e053-dadaa90a6e4eHYGIEE
81299-001-052022-07-29C16284748780-1e4f33bdf-9c62-d8a0-e053-dadaa90a6e4eHYGIEE
81299-001-062022-07-29C16284748780-1e4f33bdf-9c62-d8a0-e053-dadaa90a6e4eHYGIEE
81299-001-072022-07-29C16284748780-1e4f33bdf-9c62-d8a0-e053-dadaa90a6e4eHYGIEE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81299-001-01HYGIEE Hand sanitizer30 mL in 1 BOTTLEGEL301
81299-001-02HYGIEE Hand sanitizer50 mL in 1 BOTTLEGEL501
81299-001-03HYGIEE Hand sanitizer60 mL in 1 BOTTLEGEL601
81299-001-04HYGIEE Hand sanitizer100 mL in 1 BOTTLEGEL1001
81299-001-05HYGIEE Hand sanitizer250 mL in 1 BOTTLEGEL2501
81299-001-06HYGIEE Hand sanitizer500 mL in 1 BOTTLEGEL5001
81299-001-07HYGIEE Hand sanitizer5000 mL in 1 BOTTLEGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81299-001HYGIEE HAND SANITIZER (ETHYL ALCOHOL) GEL [AL SAFI CHEMICALS IND LLC]1Legacy NDC, 7 package rows20210113_ca30f62b-d7ff-4f07-8b31-7d17ca2615dc.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
81299-00181299-001-01, 81299-001-02, 81299-001-03, 81299-001-04, 81299-001-05, 81299-001-06, 81299-001-07

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
b8b404fc-0ccc-cb44-e053-2995a90a4fb9ca30f62b-d7ff-4f07-8b31-7d17ca2615dc2021-01-12WarningsExact identifier
spl id: b8b404fc-0ccc-cb44-e053-2995a90a4fb9
spl set id: ca30f62b-d7ff-4f07-8b31-7d17ca2615dc

Reported adverse events (FAERS/openFDA)#

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