Klarex Cleanse Tm

Alcohol Antiseptic 80% Topical Solution

Hungaro-gal Kft
Human Otc Drug
NDC 73753-821

Klarex Cleanse Tm also known as Alcohol Antiseptic 80% Topical Solution is a human otc drug labeled by 'Hungaro-gal Kft'. National Drug Code (NDC) number for Klarex Cleanse Tm is 73753-821. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Klarex Cleanse Tm drug includes Alcohol - 80 mL/100mL . The currest status of Klarex Cleanse Tm drug is Active.

Drug Information:

Drug NDC:	73753-821
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Klarex Cleanse Tm
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Klarex Cleanse
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	tm
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Alcohol Antiseptic 80% Topical Solution
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Hungaro-gal Kft
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ALCOHOL - 80 mL/100mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	27 Mar, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	14 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	part356
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	HUNGARO-GAL KFT
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1039339
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	3K9958V90M
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
73753-821-01	1000 mL in 1 BOTTLE, PLASTIC (73753-821-01)	27 Mar, 2020	N/A	No
73753-821-02	500 mL in 1 BOTTLE, PLASTIC (73753-821-02)	27 Mar, 2020	N/A	No
73753-821-03	300 mL in 1 BOTTLE, PLASTIC (73753-821-03)	27 Mar, 2020	N/A	No
73753-821-04	125 mL in 1 BOTTLE, PLASTIC (73753-821-04)	27 Mar, 2020	N/A	No
73753-821-05	60 mL in 1 BOTTLE, PLASTIC (73753-821-05)	27 Mar, 2020	N/A	No
73753-821-06	30 mL in 1 BOTTLE, PLASTIC (73753-821-06)	27 Mar, 2020	N/A	No
73753-821-07	5000 mL in 1 BOTTLE, PLASTIC (73753-821-07)	13 May, 2020	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Klarex Cleanse Tm

Alcohol Antiseptic 80% Topical Solution

Solution
HUNGARO-GAL KFT
NDC: 73753-821

Purpose:

Use use to kill germs on the skin which may cause disease - formulated for repeated use use to kill germs on the skin which may cause disease - formulated for repeated use

Product Elements:

Klarex cleanse tm alcohol antiseptic 80% topical solution water alcohol alcohol glycerin hydrogen peroxide

Indications and Usage:

Indications and usage indicatons and usage: use for cleansing your hands when soap is not available indications and usage

Warnings:

Warnings warnings for external use only. flammable. keep away from heat or flame. warnings for external use only. flammable. keep away from heat or flame. do not use do not use * in children less than 2 month of age * on open skin wounds do not use * in children less than 2 month of age * on open skin wounds when using this product when using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse eyes thorouthly with water. when using this product stop use and ask a doctor stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition. 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. keep out of reach of children

Do Not Use:

When Using:

When using this product when using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse eyes thorouthly with water. when using this product

Dosage and Administration:

Dosage and administration dosage and administration: wet hands thoroughly with product and allow to dry without wiping dosage and administration

Stop Use:

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

Information for Patients:

Other information other information * store between 15-30oc (59-86of) * avoid freezing and excessive heat above 40oc (104of) other information * store between 15-30oc (59-86of) * avoid freezing and excessive heat above 40oc (104of)

Package Label Principal Display Panel:

Principal display panel klarex cleanse tm alcohol antiseptic 80% topical solution non-sterile solution e 33.8 fl oz (1000ml) hand sanitizer who-recommended hand sanitizer formulation kills 99.9% of germs klarex cleanse tm alcohol antiseptic 80% topical solution non-sterile solution e 33.8 fl oz (1000ml) hand sanitizer who-recommended hand sanitizer formulation kills 99.9% of germs

Klarex clear principal display panel klarex cler hand sanitizer klarex clear principal display panel

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.