FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Gabe, Inc.
Effective date
2021-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:48:12

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

■ Hand sanitizer to help reduce germs on the skin that can potentially cause disease. ■ Recommended for repeated use.

Dosage and administration

■ Wet hands thoroughly with product. ■ Rub hands together for 15 seconds, pay attention between fingers, fingernails and cuticles. ■ Allow to dry without wiping.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Drug Facts

SPL UNCLASSIFIED SECTION

.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62% v/v. Purpose: Antiseptic

Uses

INDICATIONS & USAGE SECTION

■ Hand sanitizer to help reduce germs on the skin that can potentially cause disease. ■ Recommended for repeated use.

Warnings

WARNINGS SECTION

■ For external use only.
■ Flammable: Keep away from fire or flame.

OTC - WHEN USING SECTION

When using this product ■ Keep out of eyes. In case of eye contact, flush eyes with water. ■ Avoid contact with broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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

■ Wet hands thoroughly with product. ■ Rub hands together for 15 seconds, pay attention between fingers, fingernails and cuticles.

■ Allow to dry without wiping.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera, FD&C Blue #1, FD&C Yellow #5, Fragrance, PEG/PPG18/18 Dimethicone, Tocopheryl Acetate, Water

Questions or comments?

OTC - QUESTIONS SECTION

1-855-385-8555

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118.3 mL NDC: 81218-1000-1

labellabel

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
81218-100081218-1000-1

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
WATER059QF0KO0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
ecae9f7b-41f6-7930-e053-2995a90aff67beba1e25-2c9f-7a4f-e053-2995a90a1d412022-11-04WarningsExact identifier
spl set id: beba1e25-2c9f-7a4f-e053-2995a90a1d41

Reported adverse events (FAERS/openFDA)#

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