FDA.reportPublic FDA data

Ethyl Alcohol

Manufacturer
Apollo Health and Beauty Care
Effective date
2024-04-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:06:29

Label at a glance#

ProductEthyl Alcohol
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

For Personal hand hygiene to help the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Dosage and administration

For occasional and personal use. Rub thoroughly into hands for at least 30 seconds. Allow to dry. Children under 6 years should be supervised when using thiis product.

Label contents#

Full prescribing information#

Active Ingredent

OTC - ACTIVE INGREDIENT SECTION

Ethanol (70%)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For Personal hand hygiene to help the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Warnings

WARNINGS SECTION

For external use only

  • Flammable
  • Keep away from source of heat or fire.

Do not use

OTC - DO NOT USE SECTION

  • on infants less than 2 months of age.
  • on open skin wounds.
  • on broken or damaged skin.

When using this product avoid

OTC - WHEN USING SECTION

  • Contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • Do not inhale.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or redness develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For occasional and personal use.
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry.
  • Children under 6 years should be supervised when using thiis product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), PEG-6, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Fragrance (Parfum), Glycerin, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Yellow 5 (CI 19140), Blue 1 (CI 42090).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-160ETHYL ALCOHOL (ALCOHOL) GEL [APOLLO HEALTH AND BEAUTY CARE]3Unmatched20240405_0d5f4926-bb54-b118-e063-6294a90a84ed.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63148-16063148-160-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)2N8MDB79NAIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
BASIC YELLOW 507BP340B4TIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
DIRECT BLUE 18NN34MAQ6HIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
5115a0ac-dbd7-1b34-e063-6294a90a8b600d5f4926-bb54-b118-e063-6294a90a84ed2026-05-05WarningsExact identifier
spl set id: 0d5f4926-bb54-b118-e063-6294a90a84ed

Reported adverse events (FAERS/openFDA)#

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