KAS SPIRITS HAND SANITIZER: Package Insert and Label Information

KAS SPIRITS HAND SANITIZER- alcohol liquid
KAS SPIRITS LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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)

Alcohol 80% v/v. Purpose: Antiseptic

KAZAP complete label
(click image for full-size original)

Purpose

Purpose

Antiseptic

Use(s)

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

Warnings

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

Do not use

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.

Stop use

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

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 children under 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

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 Display
(click image for full-size original)
KAS SPIRITS HAND SANITIZER kas spirits hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74636-0001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 47.32 mL in 59.15 mL
Inactive Ingredients
Ingredient Name Strength
HYDROGEN PEROXIDE 0.0739 mL in 59.15 mL
WATER 10.89 mL in 59.15 mL
GLYCEROL FORMAL 0.866 mL in 59.15 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74636-0001-1 59.15 mL in 1 BOTTLE, PLASTIC None
2 NDC:74636-0001-2 354.88 mL in 1 BOTTLE, PLASTIC None
3 NDC:74636-0001-3 1892.7 mL in 1 BOTTLE, PLASTIC None
4 NDC:74636-0001-4 473 mL in 1 BOTTLE, PLASTIC None
5 NDC:74636-0001-5 3785.4 mL in 1 BOTTLE, PLASTIC None
6 NDC:74636-0001-6 177.4 mL in 1 BOTTLE, PLASTIC None
7 NDC:74636-0001-7 1000 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/04/2020
Labeler — KAS SPIRITS LLC (085186376)
Establishment
Name Address ID/FEI Operations
KAS SPIRITS LLC 085186376 manufacture (74636-0001)

Revised: 06/2020 KAS SPIRITS LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.