SPL v3
SPL
SPL Set ID ebf0d903-6796-4716-8bd9-d33d4db8b8d0
Route
TOPICAL
Published
Effective Date 2020-06-06
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 2020-05-16
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

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

Indications and Usage

Use[s]

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

Dosage and Administration

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.
Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

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

Section 50570-1

Do not use

  • in children less than 2 months of age
  • on open skin wounds
Section 51727-6

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient[s]

Alcohol 70%

Section 60561-8

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Principal Display Package

​DISTRIBUTED BY

KERN SANI, INC.

5016 CALIFORNIA AVE. - SUITE 3

BAKERSFIELD, CA 93309

HAND SANITIZER

NON-STERILE SOLUTION

ALCOHOL ANTISEPTIC 70%

TOPICAL SOLUTION

4 OUNCES (118 ML)

8 OZ

16 OZ

32 OZ

1 Gal

5 Gal

50 Gal

res

Structured Label Content

Indications and Usage (34067-9)

Use[s]

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

Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

Warnings

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

Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use

  • in children less than 2 months of age
  • on open skin wounds
Section 51727-6 (51727-6)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient[s]

Alcohol 70%

Section 60561-8 (60561-8)

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Principal Display Package

​DISTRIBUTED BY

KERN SANI, INC.

5016 CALIFORNIA AVE. - SUITE 3

BAKERSFIELD, CA 93309

HAND SANITIZER

NON-STERILE SOLUTION

ALCOHOL ANTISEPTIC 70%

TOPICAL SOLUTION

4 OUNCES (118 ML)

8 OZ

16 OZ

32 OZ

1 Gal

5 Gal

50 Gal

res

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:48.342941 · Updated: 2026-03-14T22:59:56.071430