KAS SPIRITS HAND SANITIZER

Manufacturer
KAS SPIRITS LLC
Effective date
2020-06-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:16:03

Label at a glance#

ProductKAS SPIRITS HAND SANITIZER
Active ingredientALCOHOL
Label structure13 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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

KAZAP complete labelKAZAP complete label

Purpose

OTC - PURPOSE SECTION

Purpose

Antiseptic

Use(s)

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

WARNINGS SECTION

Warnings

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

Do not use

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.

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.

Stop use

OTC - STOP USE SECTION

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KAZAP

Alcohol Antiseptic 80%
Topical Solution
Hand Sanitizer Non-sterile Solution
2 fl. oz. (59ml) NDC 74636-001-01

Drug Facts
Active ingredient[s] Purpose
Alcohol 80% v/v............................................................................................Antiseptic
Use[s]
Hand Sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are not available.
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.
Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center right away.
Directions
• Place enough product on hands to cover all surfaces.Rub hands together until dry.
• Supervise childrenunder 6 years of age when using this product to avoid swallowing.
Other information
• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients glycerin, hydrogen peroxide, purified water USP
MANUFACTURED BY
KAS SPIRITS
MAHOPAC, NY 10541
(845) 750-6000

Package Label DisplayPackage Label Display

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN5
1039339ethanol 0.8 ML/ML Topical SolutionSCD5
1039339ethanol 80 % Topical SolutionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74636-0001-1KAS SPIRITS HAND SANITIZER59.15 mL in 1 BOTTLE, PLASTICLIQUID59.155
74636-0001-2KAS SPIRITS HAND SANITIZER354.88 mL in 1 BOTTLE, PLASTICLIQUID354.885
74636-0001-3KAS SPIRITS HAND SANITIZER1892.7 mL in 1 BOTTLE, PLASTICLIQUID1892.75
74636-0001-4KAS SPIRITS HAND SANITIZER473 mL in 1 BOTTLE, PLASTICLIQUID4735
74636-0001-5KAS SPIRITS HAND SANITIZER3785.4 mL in 1 BOTTLE, PLASTICLIQUID3785.45
74636-0001-6KAS SPIRITS HAND SANITIZER177.4 mL in 1 BOTTLE, PLASTICLIQUID177.45
74636-0001-7KAS SPIRITS HAND SANITIZER1000 mL in 1 BOTTLE, PLASTICLIQUID10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74636-0001KAS SPIRITS HAND SANITIZER LIQUID [KAS SPIRITS LLC]5Legacy NDC, 7 package rows20200605_a278d614-3935-4d39-e053-2a95a90a22ee.zip

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
74636-000174636-0001-1, 74636-0001-2, 74636-0001-3, 74636-0001-4, 74636-0001-5, 74636-0001-6, 74636-0001-7

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
a74933bf-b590-2b6a-e053-2a95a90a0c50a278d614-3935-4d39-e053-2a95a90a22ee2020-06-04WarningsExact identifier
spl id: a74933bf-b590-2b6a-e053-2a95a90a0c50
spl set id: a278d614-3935-4d39-e053-2a95a90a22ee

Reported adverse events (FAERS/openFDA)#

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