SPL v1
SPL
SPL Set ID a2ffb71c-b2ef-af75-e053-2a95a90ae028
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.8 mL)
Inactive Ingredients
Glycerin Water Hydrogen Peroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30
Description

Ethyl alcohol 80%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 80%

Uses

Hand sanitizer to help reduce bacteria on hands.

Recommended for repeated use.

Warnings

For external use only.

Flammable - Keep away from fire or flame

Directions
  • Apply a small amount onto hands and rub briskly until dry.
  • Supervise children in the use of this product.
Other Information
  • Store at 15-30ºC (59-86ºF)
  • Avoid freezing and excessive heat above 40 ºC (104ºF)
Active Ingredient(s)

Ethyl alcohol 80%

Inactive Ingredients

Water, Glycerin, Hydrogen Peroxide

When Using This Product
  • Keep out of eyes, ear and mouth.
  • In case of contact with eyes, rinse eyes thoroughly with water.
Stop Use and Ask A Doctor

if irritation and redness develop or increase.

Keep Out of Reach of Children

if swallowed, get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel

500 mL NDC: 73330-0012-1

100 mL NDC: 73330-0012-2

Structured Label Content

Uses

Hand sanitizer to help reduce bacteria on hands.

Recommended for repeated use.

Purpose

Antiseptic

Warnings

For external use only.

Flammable - Keep away from fire or flame

Directions
  • Apply a small amount onto hands and rub briskly until dry.
  • Supervise children in the use of this product.
Other Information (Other information)
  • Store at 15-30ºC (59-86ºF)
  • Avoid freezing and excessive heat above 40 ºC (104ºF)
Active Ingredient(s)

Ethyl alcohol 80%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Hydrogen Peroxide

When Using This Product (When using this product)
  • Keep out of eyes, ear and mouth.
  • In case of contact with eyes, rinse eyes thoroughly with water.
Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation and redness develop or increase.

Keep Out of Reach of Children (Keep out of reach of children)

if swallowed, get medical help or contact a Poison Control Center right away.

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

500 mL NDC: 73330-0012-1

100 mL NDC: 73330-0012-2

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:11.934911 · Updated: 2026-03-14T22:56:09.845676