SPL v1
SPL
SPL Set ID d791c630-6727-4711-962b-ee4552b20965
Route
TOPICAL
Published
Effective Date 2020-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Hydrogen Peroxide Denatonium Benzoate Carbomer Homopolymer, Unspecified Type Trolamine .alpha.-tocopherol Acetate Aloe Vera Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-03
Description

Ethyl alcohol 75% v/v.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 75% v/v.

Use

To help reduce bacteria on the skin.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

Place enough product on hands to cover all surfaces. Rub hands together for 15 seconds until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient

Ethyl alcohol 75% v/v.

Inactive Ingredients

Glycerin, Hydrogen Peroxide, Denatonium Benzoate, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Distilled Water, Fragrance.

Package Label Principal Display Panel

Structured Label Content

Use

To help reduce bacteria on the skin.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

Place enough product on hands to cover all surfaces. Rub hands together for 15 seconds until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient

Ethyl alcohol 75% v/v.

Inactive Ingredients (Inactive ingredients)

Glycerin, Hydrogen Peroxide, Denatonium Benzoate, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Distilled Water, Fragrance.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:24.902841 · Updated: 2026-03-14T22:57:55.937889