Advanced Hand Sanitizer
Alcohol
Harmon Stores, Inc
Human Otc Drug
NDC 63940-439Advanced Hand Sanitizer also known as Alcohol is a human otc drug labeled by 'Harmon Stores, Inc'. National Drug Code (NDC) number for Advanced Hand Sanitizer is 63940-439. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Advanced Hand Sanitizer drug includes Alcohol - 616 mL/mL . The currest status of Advanced Hand Sanitizer drug is Active.
Drug Information:
| Drug NDC: | 63940-439 |
| 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: | Advanced Hand Sanitizer |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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: | Harmon Stores, 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 - 616 mL/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: | 18 Feb, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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: | part333A |
| 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: | Harmon Stores, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| 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 |
|---|
| 63940-439-16 | 59 mL in 1 BOTTLE, PLASTIC (63940-439-16) | 18 Feb, 2014 | N/A | No |
| 63940-439-34 | 236 mL in 1 BOTTLE, PLASTIC (63940-439-34) | 18 Feb, 2014 | N/A | No |
| 63940-439-45 | 946 mL in 1 BOTTLE, PLASTIC (63940-439-45) | 18 Feb, 2014 | 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. |
Purpose:
Purpose antiseptic
Product Elements:
Advanced hand sanitizer alcohol alcohol alcohol water aloe vera leaf glyceryl caprylate/caprate glycerin isopropyl myristate .alpha.-tocopherol acetate carbomer copolymer type b (allyl pentaerythritol crosslinked) sulisobenzone fd&c blue no. 1 fd&c yellow no. 5
Indications and Usage:
Uses to decrease bacteria on the skin that could cause disease recommend for repeated use
Warnings:
Warnings for external use only-hands flammable. keep away from heat and flame.
When Using:
When using this product keep out of eyes. in case of contact with eyes, flush thoroughly with water. avoid contact with broken skin do not inhale or ingest
Dosage and Administration:
Directions wet hands thoroghly with product and allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants
Stop Use:
Stop use and ask a doctor if irritation or redness develops condition persists for more than 72 hours
Package Label Principal Display Panel:
Principal display panel facevalues compare to purell advanced hand sanitizer kills more than 99.99% of germs** moisturizing formula with vitamin e leaves hands feeling soft with aloe 2 fl oz (59 ml) image description