Clean N Natural Hand Sanitizer Antimicrobial

Alcohol


Garcoa, Inc.
Human Otc Drug
NDC 67385-026
Clean N Natural Hand Sanitizer Antimicrobial also known as Alcohol is a human otc drug labeled by 'Garcoa, Inc.'. National Drug Code (NDC) number for Clean N Natural Hand Sanitizer Antimicrobial is 67385-026. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Clean N Natural Hand Sanitizer Antimicrobial drug includes Alcohol - 700 mg/mL . The currest status of Clean N Natural Hand Sanitizer Antimicrobial drug is Active.

Drug Information:

Drug NDC: 67385-026
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: Clean N Natural Hand Sanitizer Antimicrobial
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Clean N Natural Hand Sanitizer
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: Antimicrobial
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
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Garcoa, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Gel
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 - 700 mg/mL
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: 04 Jun, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 28 Jan, 2025
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: part333E
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:Garcoa, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:581662
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.
UPC:0038488704042
UPC stands for Universal Product Code.
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
67385-026-0159 mL in 1 BOTTLE, PLASTIC (67385-026-01)04 Jun, 2020N/ANo
67385-026-02354 mL in 1 BOTTLE, PLASTIC (67385-026-02)04 Jun, 2020N/ANo
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.

Purpose:

Purpose antimicrobial

Product Elements:

Clean n natural hand sanitizer antimicrobial alcohol alcohol alcohol carbomer interpolymer type a (allyl sucrose crosslinked) aminomethylpropanol lemon oil, cold pressed glycerin isopropyl myristate propylene glycol .alpha.-tocopherol acetate, dl- water

Indications and Usage:

Uses ? hand sanitizer to help reduce bacteria on the skin that could cause disease ? recommended for repeated use

Warnings:

Warnings flammable. keep away from fire or flame. for external use only. when using this product do not use in or near the eyes. in case of contact, rinse eyes thoroughly with water. stop use and ask a doctor if irritation or rash appears and lasts.. keep out of reach of children. if swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.

When Using:

When using this product do not use in or near the eyes. in case of contact, rinse eyes thoroughly with water.

Dosage and Administration:

Directions ? place enough product in your palm to thoroughly cover your hands ? rub hands together briskly until dry. ? children under 6 years of age should be supervised when using this product.

Stop Use:

Stop use and ask a doctor if irritation or rash appears and lasts..

Package Label Principal Display Panel:

Principal display panel - 59 ml bottle label clean n' natural ® hand sanitizer alcohol 70% based alcohol based formula helps reduce pathogenic germs on hands with moisturizers and vitamin e works without water 2 fl. oz. (59 ml) principal display panel - 59 ml bottle label

Further Questions:

Questions or comments? 1-866-567-8600


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.