Hand Sanitizer

Manufacturer
Chemical Consultants Inc
Effective date
2020-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:30:56

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure23 sections

Dosage and administration

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

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.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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.
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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel IBC 1230000 ml 77685-001-11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1230000 ml 77685-001-11 1230 L IBC1230 L IBC

2oz, 60ml spray bottle 77685-001-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77685-001-01 60ml spray bottle60ml spray bottle

4 oz/ 120 ml spray bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

120 ml 77685-001-02 4 oz /120 ml spray bottle4 oz /120 ml spray bottle

6 oz / 180ml spray bottle 77685-001-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

180 ml 77685-001-03 6 oz / 180ml spray bottle6 oz / 180ml spray bottle

8 oz / 240 ml spray bottle 77685-001-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

240 ml 77685-001-04 240ml / 8 oz spray bottle240ml / 8 oz spray bottle

475 ml / 16 oz spray bottle 77685-001-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

475 ml 77685-001-05 475 ml / 16oz spray bottle475 ml / 16oz spray bottle

946 ml / 32oz spray bottle 77685-001-06

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

946 ml 77685-001-06 946 ml / 32 oz spray bottle946 ml / 32 oz spray bottle

3785 ml / 128 oz jug 77685-001-07

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 ml 77685-001-07 3785 ml / 128 oz jug3785 ml / 128 oz jug

18900 ml 640 oz container 77685-001-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

18900 ml 77685-001-08 18900 ml / 640 oz jug18900 ml / 640 oz jug

208000 ml / 7040 oz drum 77685-001-09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

208000 ml 77685-001-09 208000 ml / 7040 oz drum208000 ml / 7040 oz drum

1040000 ml 35,200 oz ibc 77685-001-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1040000ml 77685-001-10 1040000 ml IBC1040000 ml IBC

Products#

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NDC Codes#

Ingredients#

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

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Source Document#

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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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d57b3ead-c8c9-7daa-e053-2a95a90ae8fba575db51-3549-2943-e053-2995a90a10e12022-01-13WarningsExact identifier
spl set id: a575db51-3549-2943-e053-2995a90a10e1

Reported adverse events (FAERS/openFDA)#

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