Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e4c9a66e-9f37-4b79-8b50-42736afc2897
Route
TOPICAL
Published
Effective Date 2018-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Propylene Glycol Isopropyl Alcohol Carbomer 934 Aminomethylpropanol Sulisobenzone Glycerin Mannitol Powdered Cellulose Hypromelloses Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-06-17
Description

Ethyl Alcohol 65%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Uses

To help reduce bacteria on the skin.

Warnings

For external use only

  • Flammable
  • Keep away from source of heat or fire
Directions
  • Put enough hand sanitizer in your palm to cover hands and rub hands together until dry.
  • Children under 6 years should be supervised when using this product.
Label Copy

Active Ingredient

Ethyl Alcohol 65%

Other Information
  • Store at a temperature below 110°F (43°C)
  • May discolor certain fabrics or surfaces
Inactive Ingredients

Water (Aqua), Propylene Glycol, Isopropyl Alcohol, Carbomer, Aminomethyl Propanol, Benzophenone-4, Glycerin, Fragrance (Parfum), Mannitol, Cellulose, Hydroxyethylcellulose, Iron Oxides (CI 77491, CI 77492, CI 77499), Blue 1 (CI 42090), Red 40 (CI 16035), Yellow 5 (CI 19140).

When Using This Product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If

irritation or redness develops and lasts.

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately. 1-800-222-1222

Structured Label Content

Uses

To help reduce bacteria on the skin.

Purpose

Antiseptic

Warnings

For external use only

  • Flammable
  • Keep away from source of heat or fire
Directions
  • Put enough hand sanitizer in your palm to cover hands and rub hands together until dry.
  • Children under 6 years should be supervised when using this product.
Label Copy

Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

Other Information (Other information)
  • Store at a temperature below 110°F (43°C)
  • May discolor certain fabrics or surfaces
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Propylene Glycol, Isopropyl Alcohol, Carbomer, Aminomethyl Propanol, Benzophenone-4, Glycerin, Fragrance (Parfum), Mannitol, Cellulose, Hydroxyethylcellulose, Iron Oxides (CI 77491, CI 77492, CI 77499), Blue 1 (CI 42090), Red 40 (CI 16035), Yellow 5 (CI 19140).

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation or redness develops and lasts.

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. 1-800-222-1222

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:35.445038 · Updated: 2026-03-14T22:55:09.496341