Pdi Sani-hands Instant Hand Sanitizing Wipes
Alcohol
Professional Disposables International, Inc.
Human Otc Drug
NDC 10819-3917Pdi Sani-hands Instant Hand Sanitizing Wipes also known as Alcohol is a human otc drug labeled by 'Professional Disposables International, Inc.'. National Drug Code (NDC) number for Pdi Sani-hands Instant Hand Sanitizing Wipes is 10819-3917. This drug is available in dosage form of Cloth. The names of the active, medicinal ingredients in Pdi Sani-hands Instant Hand Sanitizing Wipes drug includes Alcohol - .659 mL/mL . The currest status of Pdi Sani-hands Instant Hand Sanitizing Wipes drug is Active.
Drug Information:
| Drug NDC: | 10819-3917 |
| 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: | Pdi Sani-hands Instant Hand Sanitizing Wipes |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Pdi Sani-hands |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Instant Hand Sanitizing Wipes |
| 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: | Professional Disposables International, Inc. |
| 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: | ALCOHOL - .659 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: | 24 Mar, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | Professional Disposables International, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1251416
|
| 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. |
| 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 |
|---|
| 10819-3917-1 | 500 mL in 1 CANISTER (10819-3917-1) | 24 Mar, 2014 | N/A | No |
| 10819-3917-2 | 814 mL in 1 CANISTER (10819-3917-2) | 24 Mar, 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:
Pdi sani-hands instant hand sanitizing wipes alcohol water propylene glycol glycerin aloe vera leaf alpha-tocopherol acetate alcohol alcohol
Indications and Usage:
Uses to decrease bacteria on the skin
Warnings:
Warnings for external use only flammable. keep away from fire or flame. when using this product avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water do not use in or contact with eyes. stop use and ask a doctor if irritation or redness develops and continues for more than 72 hours discontinue use if irritation and redness develop. if condition for more persists for more than 72 hours, consult a doctor
Dosage and Administration:
Directions - to start feed: remove cover and discard seal from container. from center of toweled roll, pull up wipe corner; tear off first wipe for use. twist next wipe into a point and thread through the hole in the container cover. pull through about one inch. replace cover. pull out wipes as needed and snap off at a 90 o angle. keep cap closed to prevent evaporation. - wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. be sure to utilize the entire wipe surface. allow to dry. - if hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe. sanitize with a second wipe. - discard after single use.
Package Label Principal Display Panel:
Principal display panel front 135 ct back 135ct front 220 ct back 200 ct front 135 back 135 front back