SPL v1
SPL
SPL Set ID a7aa8f34-494d-3759-e053-2a95a90acac7
Route
TOPICAL
Published
Effective Date 2020-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-14
Description

Ethanol, 65% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethanol, 65% v/v

Use(s)

Hand sanitizer to help reduce bacterial that potentially can cause disease. For use when soap and water are not available.

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 when using this product to avoid swallowing.
Do Not Use
  • in children less than 2 months of age.
  • on open skin wounds.
Active Ingredient

Ethanol, 65% v/v

Other Information

Store between 15-30°C (59-86°F)

Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

Glycerin, hydrogen peroxide, purified water USP

Questions Or Comments?

320-693-2477

Principal Display Panel

3785 ml NDC: 63131-9049

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.
Keep Out of Reach of Children.
  • if swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use(s)

Hand sanitizer to help reduce bacterial that potentially can cause disease. For use when soap and water are not available.

Purpose

Antiseptic

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 when using this product to avoid swallowing.
Do Not Use (Do not use)
  • in children less than 2 months of age.
  • on open skin wounds.
Active Ingredient (Active ingredient)

Ethanol, 65% v/v

Other Information (Other information)

Store between 15-30°C (59-86°F)

Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients (Inactive ingredients)

Glycerin, hydrogen peroxide, purified water USP

Questions Or Comments? (Questions or comments?)

320-693-2477

Principal Display Panel

3785 ml NDC: 63131-9049

When Using This Product (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 (Stop use and ask a doctor if)
  • irritation or rash occurs. These may be signs of a serious condition.
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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:57:52.885399 · Updated: 2026-03-14T22:57:10.859448