SPL v1
SPL
SPL Set ID 68ba65c6-4ba7-44fe-a443-6ec4bec77414
Route
TOPICAL
Published
Effective Date 2017-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Carbomer 934 Aminomethylpropanol .alpha.-tocopherol Acetate, Dl- Isopropyl Alcohol Isopropyl Myristate Aloe Vera Leaf Glycerin Mannitol Powdered Cellulose Hypromelloses Ferric Oxide Red D&c Red No. 33 Fd&c Red No. 40 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-05-16
Description

Ethyl Alcohol 65%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Uses
  • to decrease bacteria on the skin.
Warnings
  • For external use only
  • Flammable. Keep away from source of heat or fire
Directions
  • apply a small amount to your palm and rub hands together briskly until dry.
  • children under 6 years old should be supervised when using this product.
Label Copy

Active Ingredient

Ethyl Alcohol 65%

Other Information
  • store at a room temperature below 110°F (43°C)
Inactive Ingredients

Water (Aqua), Fragrance (Parfum), Carbomer, Aminomethyl Propanol, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Glycerin, Mannitol, Cellulose, Hydroxypropyl Methylcellulose, Iron Oxides (CI 77491), Red 33 (CI 17200), Red 40 (CI 16035), Yellow 5 (CI 19140).

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse with water.
Keep Out of Reach of Children.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Stop Using This Product and Ask Doctor If
  • irritation or redness develops and lasts.

Structured Label Content

Uses
  • to decrease bacteria on the skin.
Purpose

Antiseptic

Warnings
  • For external use only
  • Flammable. Keep away from source of heat or fire
Directions
  • apply a small amount to your palm and rub hands together briskly until dry.
  • children under 6 years old should be supervised when using this product.
Label Copy

Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

Other Information (Other information)
  • store at a room temperature below 110°F (43°C)
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Fragrance (Parfum), Carbomer, Aminomethyl Propanol, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Glycerin, Mannitol, Cellulose, Hydroxypropyl Methylcellulose, Iron Oxides (CI 77491), Red 33 (CI 17200), Red 40 (CI 16035), Yellow 5 (CI 19140).

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse with water.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Stop Using This Product and Ask Doctor If (Stop using this product and ask doctor if)
  • irritation or redness develops and lasts.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:19.393535 · Updated: 2026-03-14T22:54:43.254033