Sanidry Wipes
Disinfectant Cleaning Wipes
Quimica Rosmar S.a. De C.v.
Human Otc Drug
NDC 77251-002Sanidry Wipes also known as Disinfectant Cleaning Wipes is a human otc drug labeled by 'Quimica Rosmar S.a. De C.v.'. National Drug Code (NDC) number for Sanidry Wipes is 77251-002. This drug is available in dosage form of Cloth. The names of the active, medicinal ingredients in Sanidry Wipes drug includes Benzalkonium Chloride - .133 1/1001 . The currest status of Sanidry Wipes drug is Active.
Drug Information:
| Drug NDC: | 77251-002 |
| 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: | Sanidry 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: | Disinfectant Cleaning Wipes |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Quimica Rosmar S.a. De C.v. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cloth |
| 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: | BENZALKONIUM CHLORIDE - .133 1/1001
|
| 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: | 28 May, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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: | QUIMICA ROSMAR S.A. DE C.V.
|
| 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: | F5UM2KM3W7
|
| 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 |
|---|
| 77251-002-01 | 300 CLOTH in 1 PACKAGE (77251-002-01) | 28 May, 2020 | N/A | No |
| 77251-002-02 | 1200 CLOTH in 1 PACKAGE (77251-002-02) | 28 May, 2020 | N/A | No |
| 77251-002-03 | 40 CLOTH in 1 BOX (77251-002-03) | 28 May, 2020 | N/A | No |
| 77251-002-04 | 100 CLOTH in 1 BAG (77251-002-04) | 28 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. |
Purpose:
Purpose antiseptic
Product Elements:
Sanidry wipes disinfectant cleaning wipes water alcohol glycerin edetate sodium benzalkonium chloride benzalkonium
Indications and Usage:
Uses for hand sanitizing to decrease bacteria on the skin when water and soap are not available recommended for repeated use.
Warnings:
Warnings for external use only. flammable: keep away from fire or flame.
When Using:
When using this product do not use in near eyes. if contact occurs, flush thoroughly with water.
Dosage and Administration:
Directions remove wipe wet hand thoroughly with wipe and allow hands to dry without wiping.
Stop Use:
Stop use and contact a doctor if irritation or redness persists for more than 72 hours.
Package Label Principal Display Panel:
300 wipes - ndc 77251-002-01 1200 wipes - ndc 77251-002-02 40 wipes - ndc 77251-002-03 100 wipes - ndc 77251-002-04 label-77251-002-01 label-77251-002-02 label label