SPL v4
SPL
SPL Set ID 87e34c76-006d-4f90-a564-1a16b1698405
Route
TOPICAL
Published
Effective Date 2020-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (80 mL)
Inactive Ingredients
Glycerin Water Aminomethylpropanol Ceteareth-5 Cyclohexane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-28
Description

Ethyl Alcohol 80% v/v

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 80% v/v

Use

Hand Sanitizer to help reduce bacteria on skin.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help and call Poison Control.

Section 50567-7

When using this product avoid mouth, eyes and ears. In case of contact with eyes, flush with water.

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

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Ethyl Alcohol 80% v/v

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

Water,Glycerin, Thickener, Ph balancer, Fragrance

Package Label Principal Display Panel

Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on skin.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help and call Poison Control.

Section 50567-7 (50567-7)

When using this product avoid mouth, eyes and ears. In case of contact with eyes, flush with water.

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

Purpose

Antimicrobial

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Ethyl Alcohol 80% v/v

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

Water,Glycerin, Thickener, Ph balancer, 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: 2026-02-15T12:00:16.772658 · Updated: 2026-03-14T23:00:39.941399