f1755c79-bce1-4e2a-8c4c-29271581c1d0

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
Purpose

Antibacterial

Description

Alcohol 75% v/v.

Medication Information

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.

Uses

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

Purpose

Antibacterial

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

Aminomethylpropanol, Carbomer, Glycerin, Purified water USP

Description

Alcohol 75% v/v.

Section 50565-1

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

Active Ingredient

Alcohol 75% v/v.

Package Label Principal Display Panel

Structured Label Content

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.

Uses

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

Purpose

Antibacterial

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.
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

Section 50565-1 (50565-1)

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

Active Ingredient

Alcohol 75% v/v.

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