SPL v4
SPL
SPL Set ID f1755c79-bce1-4e2a-8c4c-29271581c1d0
Route
TOPICAL
Published
Effective Date 2020-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Glycerin Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-27
Description

Alcohol 75% v/v.

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Alcohol 75% v/v.

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 productkeep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

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.
Active Ingredient

Alcohol 75% v/v.

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

Aminomethylpropanol, Carbomer, Glycerin, Purified water USP

Package Label Principal Display Panel

Structured Label Content

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

Antibacterial

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 productkeep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

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.
Active Ingredient

Alcohol 75% v/v.

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

Aminomethylpropanol, Carbomer, Glycerin, Purified water USP

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: 2026-02-15T12:04:07.929801 · Updated: 2026-03-14T23:13:00.870746