FDA.reportPublic FDA data

Hand Sanitizer Gel

Manufacturer
Ulano Corporation
Effective date
2021-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:22:30

Label at a glance#

ProductHand Sanitizer Gel
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place bead of product onto dry palms. Spread evenly to cover hands. Rub lightly until dry. Children under 6 years should be supervised when using this product.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s) Ethyl Alcohol min 78% v/v

OTC - ACTIVE INGREDIENT SECTION

Drug Facts PanelDrug Facts Panel

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient(s) Purpose

Ethyl Alcohol min 78% v/v............................................Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand sanitizer gel to decrease viruses and bacteria that can potentially cause desease.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

  • on open skin wounds
  • in children under 1 year of age

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a more 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place bead of product onto dry palms.
  • Spread evenly to cover hands.
  • Rub lightly until dry.
  • Children under 6 years should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin USP, Purified water, HydroxyPropylCellulose, Hydrogen Peroxide, Lemon(Citrus limon) Peel Oil distilled, Linalool, Linalyl Acetate

Package Label - Principal Display Panel 90 mL NDC: 80757-010-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display panelPrincipal Display panel

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80757-01080757-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
LINALYL ACETATE5K47SSQ51GIACT
LINALOOL, (+/-)-D81QY6I88EIACT
LEMON OIL, DISTILLEDET5GD00TRPIACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
d345d6c5-3163-a9db-e053-2995a90a8b48b105b4ea-905a-2684-e053-2a95a90a11f52021-12-16WarningsExact identifier
spl id: d345d6c5-3163-a9db-e053-2995a90a8b48
spl set id: b105b4ea-905a-2684-e053-2a95a90a11f5

Reported adverse events (FAERS/openFDA)#

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