Antiseptic Alcohol Wipes
Isopropyl Alcohol, Ethyl Alcohol
American Chemical And Sanitary Supply Inc
Human Otc Drug
NDC 50536-203Antiseptic Alcohol Wipes also known as Isopropyl Alcohol, Ethyl Alcohol is a human otc drug labeled by 'American Chemical And Sanitary Supply Inc'. National Drug Code (NDC) number for Antiseptic Alcohol Wipes is 50536-203. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Antiseptic Alcohol Wipes drug includes Alcohol - 62.5 mL/1 Isopropyl Alcohol - 7.5 mL/1 . The currest status of Antiseptic Alcohol Wipes drug is Active.
Drug Information:
| Drug NDC: | 50536-203 |
| 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: | Antiseptic Alcohol Wipes |
| 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, Ethyl Alcohol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | American Chemical And Sanitary Supply Inc |
| 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 - 62.5 mL/1
ISOPROPYL ALCOHOL - 7.5 mL/1
|
| 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: | 25 Jun, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 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: | 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: | AMERICAN CHEMICAL AND SANITARY SUPPLY 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
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 |
|---|
| 50536-203-15 | 150 SOLUTION in 1 CONTAINER (50536-203-15) | 25 Jun, 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 first aid antiseptic
Product Elements:
Antiseptic alcohol wipes isopropyl alcohol, ethyl alcohol water glycerin alcohol alcohol isopropyl alcohol isopropyl alcohol
Indications and Usage:
Use to decrease germs in minor cuts or scrapes.
Warnings:
For external use only flammable, keep away from fire or flame produces serious gastric disturbance if taken internally do not use as a substitute for grain or ethyl alcohol on irritated skin ask a doctor before use if you have deep or puncture wounds or serious burns when using this product avoid getting into eyes or on mucous membranes use only ina well ventilated area stop use and ask a doctor if irritation or swelling develops on the skin pain persist or increases or if infection ocurs if pregnant or breast-feeding, ask a health professional before use.
Dosage and Administration:
Directions use as many wipes as needed to clean hands thoroughly. allow product to air dry.
Package Label Principal Display Panel:
01b lbl_1203 antiseptic wipes 4x12 bis