SPL v1
SPL
SPL Set ID 58986197-5b97-4903-aaae-8f275e989f92
Route
TOPICAL
Published
Effective Date 2018-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Carbomer 934 Glycerin Isopropyl Myristate Isopropyl Alcohol Aminomethylpropanol Aloe Vera Leaf .alpha.-tocopherol Acetate, Dl- Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-10-08
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 product 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), Fragrance (Parfum), Carbomber, Glycerin, Isopropyl Myristate, Isopropyl Alcohol, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Blue 1 (CI 42090), Yellow 5 (CI 19140).

Questions Or Comments?

1-866-695-3030

When Using This Product

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

Stop Use and Ask A Doctor If

irritaiton 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.

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 product 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), Fragrance (Parfum), Carbomber, Glycerin, Isopropyl Myristate, Isopropyl Alcohol, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Blue 1 (CI 42090), Yellow 5 (CI 19140).

Questions Or Comments? (Questions or comments?)

1-866-695-3030

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)

irritaiton 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:38.791230 · Updated: 2026-03-14T22:55:16.609561