FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Bluefin International Inc
Effective date
2020-06-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:25:10

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

For Hand Sanitizing

Dosage and administration

•Wet hands thoroughly with product and allow to dry without wiping. •For children under 6 age use only under adult supervision. •Not recommended for infants.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For Hand Sanitizing

Warnings

WARNINGS SECTION

For external use only-hands.

Flammable. Keep away from heat and flame.

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.  Do not inhale or ingest.

Stop use and ask a doctor

OTC - STOP USE SECTION

if skin irritation develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or call a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

•Wet hands thoroughly with product and allow to dry without wiping.

•For children under 6 age use only under adult supervision.
•Not recommended for infants.

Other Information

SPL UNCLASSIFIED SECTION

• Do not store above 105°F.
• May discolor some fabrics.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carborner, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Package Labeling: 75295-000-15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 75295-000-30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: 75295-000-60

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Package Labeling: 759259-000-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75295-00075295-000-15, 75295-000-30, 75295-000-60, 75295-000-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
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
efcea737-bb2e-2e82-e053-2a95a90ac2d3a448bad2-f1c2-e37f-e053-2a95a90afe092022-12-14WarningsExact identifier
spl set id: a448bad2-f1c2-e37f-e053-2a95a90afe09

Reported adverse events (FAERS/openFDA)#

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