FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Bluefin International Inc
Effective date
2021-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:22:38

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

apply palmful to hands rub hands together vigorously until dry supervise children in the use of this product

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]:

INDICATIONS & USAGE SECTION

Use hand sanitizer to help reduce bacteria on the skin.

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 redness develops.

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

  • apply palmful to hands
  • rub hands together vigorously until dry
  • supervise children in the use of this product

Other Information

SPL UNCLASSIFIED SECTION

  • Store below 110°F(43° C)
  • may discolor certain fabrics or surfaces

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Hydrogen Peroxide, Methylcellulose, Purified Water USP.

Package Labeling: 120ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 236ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: 3785ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

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
75295-00175295-001-04, 75295-001-08, 75295-001-12

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
METHYLCELLULOSE, UNSPECIFIEDZ944H5SN0HIACT
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
d3353f73-6bc3-6e77-e053-2a95a90a1737a85c1736-89db-8c6a-e053-2995a90ab8d42021-12-15WarningsExact identifier
spl id: d3353f73-6bc3-6e77-e053-2a95a90a1737
spl set id: a85c1736-89db-8c6a-e053-2995a90ab8d4

Reported adverse events (FAERS/openFDA)#

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