SPL v3
SPL
SPL Set ID 2c71750e-1f7f-4ee2-af1d-7b5426a79323
Route
TOPICAL
Published
Effective Date 2020-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Water Glycerin Aminomethylpropanol Denatonium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01
Description

Alcohol 70% v/v.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 70% v/v.

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.

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 doctor if irritation and redness develop or if condition persists more than 72 hours.

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Product Label

Active Ingredient

Alcohol 70% v/v.

Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

Carbomer, Water, Glycerin, Aminomethylpropanol, Denatonium benzoate

Structured Label Content

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.

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 doctor if irritation and redness develop or if condition persists more than 72 hours.

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Product Label (Product label)

Active Ingredient

Alcohol 70% v/v.

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

Carbomer, Water, Glycerin, Aminomethylpropanol, Denatonium benzoate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:27.028946 · Updated: 2026-03-14T22:58:00.033401