SPL v1
SPL
SPL Set ID 99e8567f-1bdf-487c-921a-2f926aad5215
Route
TOPICAL
Published
Effective Date 2020-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water .alpha.-tocopherol Acetate Denatonium Benzoate Glycerin Isopropyl Myristate Propylene Glycol Methacrylic Acid - Ethyl Acrylate Copolymer (4500 Mpa.s) Triisopropanolamine Linalool, (+)- Fragrance Lavender & Chia F-153480 Cuminyl Acetaldehyde

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-10
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. 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 product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation 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.
Product Label

Active Ingredient

Alcohol 70% v/v. 

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

glycerin, isopropyl myristate, methacrylic acid, propylene glycol, purified water USP, tetrahydroxypropyl ethylenediamine, vitamin E

Structured Label Content

Use

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

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 a doctor if irritation 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.
Product Label

Active Ingredient

Alcohol 70% v/v. 

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

glycerin, isopropyl myristate, methacrylic acid, propylene glycol, purified water USP, tetrahydroxypropyl ethylenediamine, vitamin E

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:13.572050 · Updated: 2026-03-14T22:57:40.950905