SPL v1
SPL
SPL Set ID ab127d7f-6aa9-223b-e053-2995a90ae81a
Route
TOPICAL
Published
Effective Date 2020-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Maltodextrin Aloe Vera Leaf Water Glycerin Propylene Glycol Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Aminomethylpropanol Denatonium Benzoate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-23
Description

Ethyl Alcohol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62%

Uses

For hand washing to decrease bacteria on the skin. Recommended for repeated use.

Section 50566-9

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Section 51945-4

Warnings

Flammable. Keep away from fire or flame. For external use only. Avoid contact with broken skin.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Not recommended for infants.

Children under 6 years of age should be supervised when using this product.

Active Ingredient

Ethyl Alcohol 62%

Other Information
  • Do not store above 1109F (43℃).
  • May discolor some fabrics.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C1O-30 Alkyl Acrylate crosspolymer, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate.

Keep Out of Reach of Children.

If swallowed, get medical help.

Structured Label Content

Uses

For hand washing to decrease bacteria on the skin. Recommended for repeated use.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

Flammable. Keep away from fire or flame. For external use only. Avoid contact with broken skin.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Not recommended for infants.

Children under 6 years of age should be supervised when using this product.

Active Ingredient

Ethyl Alcohol 62%

Other Information
  • Do not store above 1109F (43℃).
  • May discolor some fabrics.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C1O-30 Alkyl Acrylate crosspolymer, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:16.528394 · Updated: 2026-03-14T22:57:45.410763