Hand Sanitizer

Hand Sanitizer
SPL v1
SPL
SPL Set ID 0bc05dc9-4cf3-4352-997d-e318ced9c067
Route
TOPICAL
Published
Effective Date 2020-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-06
Description

Alcohol 75% v/v

Purpose

Antiseptic

Medication Information

Warnings and Precautions

Warnings For external use only.

Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

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.

Purpose

Antiseptic

Description

Alcohol 75% 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

75% ALCOHOL ANTISEPTIC

Topical Solution

Non-sterile Solution

NO ANIMAL TESTING    

parabens FREE

Made in México.

Imported & distributed by:

Frozen Wheels, LLC

16565 NW 15th Ave.

Miami, FL 33169

QUESTIONS

786-265-1879

NOT INTENDED FOR RETAIL SALE

Section 50565-1

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

Section 51727-6

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Packaging

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.
Drug Facts

Active Ingredient

Alcohol 75% v/v

Other Information
  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

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.

Warnings and Precautions (34071-1)

Warnings For external use only.

Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

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.

Section 42229-5 (42229-5)

75% ALCOHOL ANTISEPTIC

Topical Solution

Non-sterile Solution

NO ANIMAL TESTING    

parabens FREE

Made in México.

Imported & distributed by:

Frozen Wheels, LLC

16565 NW 15th Ave.

Miami, FL 33169

QUESTIONS

786-265-1879

NOT INTENDED FOR RETAIL SALE

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Purpose

Antiseptic

Packaging

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.
Drug Facts (Drug facts)

Active Ingredient (Active ingredient)

Alcohol 75% v/v

Other Information (Other information)
  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:30.417570 · Updated: 2026-03-14T22:56:42.417712