Afco 5515 Hand Sanitizer
Isopropyl Alcohol
Alex C. Fergusson, Inc.
Human Otc Drug
NDC 68776-1007Afco 5515 Hand Sanitizer also known as Isopropyl Alcohol is a human otc drug labeled by 'Alex C. Fergusson, Inc.'. National Drug Code (NDC) number for Afco 5515 Hand Sanitizer is 68776-1007. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Afco 5515 Hand Sanitizer drug includes Isopropyl Alcohol - .7575 g/mL . The currest status of Afco 5515 Hand Sanitizer drug is Active.
Drug Information:
| Drug NDC: | 68776-1007 |
| 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: | Afco 5515 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: | Isopropyl Alcohol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alex C. Fergusson, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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: | ISOPROPYL ALCOHOL - .7575 g/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: | 16 Mar, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 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: | Alex C. Fergusson, 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: | ND2M416302
|
| 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 |
|---|
| 68776-1007-5 | 2 BAG in 1 BOX (68776-1007-5) / 2000 mL in 1 BAG | 16 Mar, 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. |
Purpose:
Purpose: antiseptic
Product Elements:
Afco 5515 hand sanitizer isopropyl alcohol isopropyl alcohol isopropyl alcohol water glycerin
Indications and Usage:
Uses helps prevent cross contamination by hand contact helps prevent drying and chafing of skin recommended for repeat use
Warnings:
Warnings for external use only
When Using:
? when using this product do not use in or near eyes. discontinue use if irritation or redness develops. use in well-ventilted area.
Dosage and Administration:
Directions: place a palmful of product in one hand spread on both hands and rub into the skin until dry (1-2 min.) no rinsing or toweling required
Stop Use:
Stop use and ask a doctor if irritation persists for more than 72 hours.
Package Label Principal Display Panel:
Product package afco 5515 hand sanitizer manufactured by: alex c. fergusson, llc 800 development avenue chambersburg, pa 17201 toll free: 800-345-1329 ndc# 68776-1007-5 batch no.: exp. date: 00/00/2000 contents: 2l (68 fl. oz.) chemtrec emergency 800-424-9300 (chemtrec customer number: ccn837) hmis hazard rating health 1 flammability 3 reactivity 0 personal protection a chemtrec emergency 800-424-9300 (chemtrec customer number: ccn837) 2-liter bag label 2 x 2l case label res 1007-5 2l bag 1007-5 2x2l box
Further Questions:
Questions or comments: for product or technical information, contact afco monday to friday 8 am to 4 pm est at 1-800-345-1329 or visit our website at www.afcocare.com