Hand Sanitizer

Manufacturer
Kemper System America, Inc.
Effective date
2020-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:37:27

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

OTC - ACTIVE INGREDIENT SECTION

Active ingredient[s]

Isopropyl alcohol 75% v/v

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Use[s]

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

WARNINGS SECTION

Warnings

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

OTC - DO NOT USE SECTION

Do not use

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

STORAGE AND HANDLING SECTION

Other information

• Store between 15-30C (59-86F)

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

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kemper LogosKemper Logos

Hand Sanitizer

WHO Recommended Formula

Isopropyl Alcohol Antiseptic 75%

Topical Solution

  • Non-sterile Solution

12 FL OZ (354 mL)

Contact Information:
Kemper System America, Inc.
1200 North America Drive
West Seneca, NY 14224
Tel.: 1-800-541-5455

41538 REV A APR 20

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73916-175-012022-01-28C16284748780-1d6a99b39-6e2b-a426-e053-dadaa90af4c2Hand Sanitizer

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73916-17573916-175-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
296601d2-35ea-3a7c-e063-6294a90a0110a18a3cde-9c05-5b21-e053-2a95a90ae9522024-12-16WarningsExact identifier
spl set id: a18a3cde-9c05-5b21-e053-2a95a90ae952

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.