Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 51d1539b-831c-4cdb-8b0a-16a32693b908
Route
TOPICAL
Published
Effective Date 2017-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Isopropyl Alcohol Propylene Glycol Glycerin Isopropyl Myristate .alpha.-tocopherol Acetate, Dl- Carbomer 934 Aminomethylpropanol Fd&c Yellow No. 5 D&c Yellow No. 10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-09-25
Description

Ethyl Alcohol 65%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Uses
  • helps reduce bacteria on the skin
Warnings

For external use only

  • flammable, keep away from fire or flame
Directions
  • wet hands thoroughly and rub together until dry
Label Copy

Active Ingredient

Ethyl Alcohol 65%

Other Information

store at a temperature below 110°F (43°C)

Inactive Ingredients

Water (Aqua), Isopropyl Alcohol, Propylene Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum), Yellow 5 (CI 19140), Yellow 10 (CI 47005).

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
  • helps reduce bacteria on the skin
Purpose

Antiseptic

Warnings

For external use only

  • flammable, keep away from fire or flame
Directions
  • wet hands thoroughly and rub together until dry
Label Copy

Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

Other Information (Other information)

store at a temperature below 110°F (43°C)

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Isopropyl Alcohol, Propylene Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum), Yellow 5 (CI 19140), Yellow 10 (CI 47005).

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

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Source: dailymed · Ingested: 2026-02-15T11:56:24.917354 · Updated: 2026-03-14T22:54:51.534540