drug facts

drug facts
SPL v1
SPL
SPL Set ID 3165d26b-3e4b-403d-9977-36dec01ff969
Route
topical
Published
Effective Date 2016-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (650 mg)
Inactive Ingredients
water propylene glycol sulisobenzone carbomer 934 glycerin .alpha.-tocopherol acetate, dl- aminomethylpropanol isopropyl myristate fd&c blue no. 1 d&c red no. 33

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-10-03
Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Medication Information

Warnings

For external use only.

  • ​Flammable. Keep away from flame or fire.
Uses

to decrease bacteria on the skin.

Purpose

Antiseptic

Directions

Apply a small amount to your palm and rub hands together briskly until dry. Children 6 years of age and under should be supervised when using this product.

Other Information

Store at a temperature below 110°F (43°C).

Inactive Ingredients

Water (Aqua), Propylene Glycol, Fragrance (Parfum), Benzophenone-4, Carbomer, Glycerin, Tocopheryl Acetate, Aminomethyl Propanol, Isopropyl Myristate, Blue 1 (CI 42090), Red 33 (CI 17200).

Description

Ethyl Alcohol 65%

Label Copy

Active Ingredient

Ethyl Alcohol 65%

Questions Or Comments?

1-866-695-3030

When Using This Product

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

Stop Use and Ask A Doctor If

irritation or redness develops and lasts.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Structured Label Content

Warnings

For external use only.

  • ​Flammable. Keep away from flame or fire.
Uses

to decrease bacteria on the skin.

Purpose

Antiseptic

Directions

Apply a small amount to your palm and rub hands together briskly until dry. Children 6 years of age and under should be supervised when using this product.

Other Information (Other information)

Store at a temperature below 110°F (43°C).

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Propylene Glycol, Fragrance (Parfum), Benzophenone-4, Carbomer, Glycerin, Tocopheryl Acetate, Aminomethyl Propanol, Isopropyl Myristate, Blue 1 (CI 42090), Red 33 (CI 17200).

Label Copy

Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

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 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.)

If swallowed, 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: 2026-02-15T11:56:10.852296 · Updated: 2026-03-14T22:54:27.650645