FDA.reportPublic FDA data

STERY Hand Sanitizer

Manufacturer
Bionomix Manufacturing, LLC.
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:04:40

Label at a glance#

ProductSTERY Hand Sanitizer
Active ingredientALCOHOL
Label structure8 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 15-30°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

Alcohol 70% 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

OTC - DO NOT USE SECTION

■ in children less than 2 months of age ■ on open skin wounds.

When using this product

OTC - WHEN USING SECTION

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

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 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 15-30°C (59-86°F) ■ Avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Carbomer Copolymer, Purified Water.

Package Labeling: 3785mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling: 500 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79131-002-012022-02-16C16284748780-1d6a99b39-7fb8-a426-e053-dadaa90af4c2STERY Hand Sanitizer
79131-002-022022-02-16C16284748780-1d6a99b39-7fb8-a426-e053-dadaa90af4c2STERY Hand Sanitizer
79131-002-012022-01-28C16284748780-1d6a99b39-7fb8-a426-e053-dadaa90af4c2STERY Hand Sanitizer
79131-002-022022-01-28C16284748780-1d6a99b39-7fb8-a426-e053-dadaa90af4c2STERY Hand Sanitizer

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79131-00279131-002-01, 79131-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
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
d826f16e-b4d2-7993-e053-2995a90a1708b57e2d81-f641-1810-e053-2995a90a9d1f2022-02-16WarningsExact identifier
spl set id: b57e2d81-f641-1810-e053-2995a90a9d1f

Reported adverse events (FAERS/openFDA)#

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