a7aa8f34-494d-3759-e053-2a95a90acac7

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
Purpose

Antiseptic

Description

Ethanol, 65% v/v

Medication Information

Warnings

For external use only. Flammable. Keep away from heat or flame.

Purpose

Antiseptic

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.
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

Description

Ethanol, 65% v/v

Principal Display Panel

3785 ml NDC: 63131-9049

Use(s)

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

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

Ethanol, 65% v/v

Questions Or Comments?

320-693-2477

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

Warnings

For external use only. Flammable. Keep away from heat or flame.

Purpose

Antiseptic

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.
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

Principal Display Panel

3785 ml NDC: 63131-9049

Use(s)

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

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

Questions Or Comments? (Questions or comments?)

320-693-2477

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

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