Hand Sanitizer 4oz

Manufacturer
LACOUR PRINTING SOLUTIONS
Effective date
2020-10-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:13:13

Label at a glance#

ProductHand Sanitizer 64oz
Active ingredientALCOHOL
Label structure9 sections

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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (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

Alcohol 70% v/v. Purpose: Antiseptic

Warnings

WARNINGS SECTION

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

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.

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.

Do not use

OTC - DO NOT USE SECTION

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

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)

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, fragrance, glycerin, trolamine, water

Package Label - 60 ML, 100 ML, 250 ML, 500 ML, 1000 ml, 1/2 gallon, 1 gallon

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 ML label60 ML label

60 mL NDC: 80563-070-02 100 ML label100 ML label100 mL NDC: 80563-071-03

120ML Label120ML Label120 mL NDC: 80563-072-04

250ml label250ml label250 mL NDC: 80563-073-08

360 ml label360 ml label360 mL NDC: 80563-074-12

500 ml label500 ml label500 mL NDC: 80563-075-16

1000 ml label1000 ml label1000 mL NDC: 80563-076-32

Half gallon labelHalf gallon label

1893 mL NDC: 80563-077-64

128 oz Gallon label128 oz Gallon label3786 mL NDC: 80563-078-99

OTC - STOP USE SECTION

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

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NDC Codes#

Ingredients#

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Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b117a102-a92a-1684-e053-2a95a90ac3b4af0fab4d-3582-db4e-e053-2a95a90ac3c32020-10-07WarningsExact identifier
spl id: b117a102-a92a-1684-e053-2a95a90ac3b4
spl set id: af0fab4d-3582-db4e-e053-2a95a90ac3c3

Reported adverse events (FAERS/openFDA)#

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