drug facts

drug facts
SPL v1
SPL
SPL Set ID 4982a1bd-a4f4-4db9-9798-9b1e9ae34348
Route
topical
Published
Effective Date 2017-09-28
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 d&c red no. 33 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-09-25
Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Medication Information

Warnings

For external use only

  • flammable, keep away from source of heat or fire
Uses
  • helps reduce bacteria on the skin
Purpose

Antiseptic

Directions
  • wet hands thoroughly and rub together until dry.
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), Red 33 (CI 17200), Yellow 5 (CI 19140).

Description

Ethyl Alcohol 65%

Label Copy

Active Ingredient

Ethyl Alcohol 65%

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly 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 A Doctor If
  • irritation or redness develops and lasts.

Structured Label Content

Warnings

For external use only

  • flammable, keep away from source of heat or fire
Uses
  • helps reduce bacteria on the skin
Purpose

Antiseptic

Directions
  • wet hands thoroughly and rub together until dry.
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), Red 33 (CI 17200), Yellow 5 (CI 19140).

Label Copy

Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly 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 A Doctor If (Stop using this product and ask a 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: 2026-02-15T11:56:25.434443 · Updated: 2026-03-14T22:54:51.534540