Topical Solution Hand Sanitizer

Topical Solution Hand Sanitizer
SPL v2
SPL
SPL Set ID 374e9524-6e81-4d1f-83aa-46ff927f37c1
Route
TOPICAL
Published
Effective Date 2020-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-25
Description

Alcohol 80% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 80% v/v

Use[s]

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

Section 42229-5
  • Store between 15-30C (104F)
  • Avoid freezing and excessive heat above 40C (104F)
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
Package Labeling:

Active Ingredient[s]

Alcohol 80% v/v

Inactive Ingredients

glycerin, hydrogen peroxide, aqua(sterile distilled water)

Stop Use and Ask A Doctor

if irritation or rash occurs. These may be signs of a serious condition.

When Using This Product 

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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 bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5 (42229-5)
  • Store between 15-30C (104F)
  • Avoid freezing and excessive heat above 40C (104F)
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
Package Labeling:

Active Ingredient[s] (Active ingredient[s])

Alcohol 80% v/v

Inactive Ingredients (Inactive ingredients)

glycerin, hydrogen peroxide, aqua(sterile distilled water)

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation or rash occurs. These may be signs of a serious condition.

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.

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: 2026-02-15T11:57:41.558982 · Updated: 2026-03-14T22:56:55.348852