FDA.reportPublic FDA data

Ethyl Alcohol

Manufacturer
Freshorize Ltd | Freshorize USA LLC
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:18:36

Label at a glance#

ProductEthyl Alcohol
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

For handwashing to decrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

Wet hands thoroughly with product Briskly rub hands together until dry supervise children under 6 years in the use of this product

Label contents#

Full prescribing information#

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Tocopheryl, Aloe Barbadensis Leaf Juice.

Directions

INSTRUCTIONS FOR USE SECTION

Wet hands thoroughly with product

Briskly rub hands together until dry

supervise children under 6 years in the use of this product

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire and flame.

Do not use in the eyes. In case of contact, rinse eyes throughly with water.
Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Other Information

OTHER SAFETY INFORMATION

Store at 20ºC to 25ºC (68º to 77ºF)

May discolour certain fabrics

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin.

Recommended for repeated use.

DOSAGE & ADMINISTRATION SECTION

There are no specific directions. It is a hand sanitizer with the directions for use to just add to your hand and briskly rub until dry.
Typical use would be one pump.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
52305-00152305-001-01, 52305-001-02, 52305-001-03, 52305-001-04

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
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 934Z135WT9208IACT

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
24b096a4-20eb-1c59-e063-6394a90aaaf4a7ac0e16-d13a-b55e-e053-2a95a90a0f392024-10-17WarningsExact identifier
spl set id: a7ac0e16-d13a-b55e-e053-2a95a90a0f39

Reported adverse events (FAERS/openFDA)#

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