87e34c76-006d-4f90-a564-1a16b1698405

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
Purpose

Antimicrobial

Description

Ethyl Alcohol 80% v/v

Medication Information

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Purpose

Antimicrobial

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age.
Other Information
  • Store in 15-30C (59-86F)
  • Avoid freezing and above 40C (104F)
Inactive Ingredients

Water,Glycerin, Thickener, Ph balancer, Fragrance

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.

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Ethyl Alcohol 80% v/v

Package Label Principal Display Panel

Structured Label Content

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Purpose

Antimicrobial

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age.
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

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.

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

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