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Kas spirits hand sanitizer - Prescription Drug Labeling

Product NDC Code 74636-0001
Drug Name

Kas spirits hand sanitizer

Type Generic
Active Ingredients
Alcohol 47.32 ml/59.15ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1039339
Application Number part333A
Labeler Name KAS SPIRITS LLC
Packages
Package NDC Code Description
74636-0001-1 59.15 ml in 1 bottle, plastic (74636-0001-1)
74636-0001-2 354.88 ml in 1 bottle, plastic (74636-0001-2)
74636-0001-3 1892.7 ml in 1 bottle, plastic (74636-0001-3)
74636-0001-4 473 ml in 1 bottle, plastic (74636-0001-4)
74636-0001-5 3785.4 ml in 1 bottle, plastic (74636-0001-5)
74636-0001-6 177.4 ml in 1 bottle, plastic (74636-0001-6)
74636-0001-7 1000 ml in 1 bottle, plastic (74636-0001-7)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient(s) Active Ingredient(s) Alcohol 80% v/v. Purpose: Antiseptic KAZAP complete label

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use(s) Use(s) Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

Information about the drug product’s indications for use.
Purpose Purpose Antiseptic

Spl product data elements

Usually a list of ingredients in a drug product.
KAS SPIRITS HAND SANITIZER KAS SPIRITS HAND SANITIZER HYDROGEN PEROXIDE ALCOHOL ALCOHOL WATER GLYCEROL FORMAL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
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: 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. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). 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.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use Do not use in children less than 2 months of age on open skin wounds

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Warnings For external use only. Flammable. Keep away from heat or flame

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API