SPL v1
SPL
SPL Set ID 6a8e1665-f871-4ad3-bf18-52db4e791aa0
Route
TOPICAL
Published
Effective Date 2020-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Glycerin Propylene Glycol Carbomer Homopolymer Type A (allyl Pentaerythritol Crosslinked) Aminomethylpropanol Aloe Vera Leaf .alpha.-tocopherol Acetate, D-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01
Description

Ethyl Alcohol 75% v/v.

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 75% v/v.

Uses

Hand Sanitizer to help reduce bacteria on the skin that potentially can cause disease. 

Section 50565-1

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

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product

  • do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.
  • avoid using on broken skin.

Stop use and ask a doctor if irritation or rash appears and lasts.

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.
Active Ingredient

Ethyl Alcohol 75% v/v.

Inactive Ingredients

Aqua, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Aloe Barbadensis (Aloe Vera) Gel, Tocopheryl Acetate (Vitamin E)

Package Label Principal Display Panel

500 mL Label

1000 mL Label

Structured Label Content

Uses

Hand Sanitizer to help reduce bacteria on the skin that potentially can cause disease. 

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

Antimicrobial

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product

  • do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.
  • avoid using on broken skin.

Stop use and ask a doctor if irritation or rash appears and lasts.

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.
Active Ingredient

Ethyl Alcohol 75% v/v.

Inactive Ingredients (Inactive ingredients)

Aqua, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Aloe Barbadensis (Aloe Vera) Gel, Tocopheryl Acetate (Vitamin E)

Package Label Principal Display Panel (Package Label - Principal Display Panel)

500 mL Label

1000 mL Label

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:48.958370 · Updated: 2026-03-14T22:57:05.210150