NDC 10819-3916 Pdi Sani-hands Instant Hand Sanitizing Wipes
Alcohol Cloth Topical

Product Information

Product Code10819-3916
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Pdi Sani-hands Instant Hand Sanitizing Wipes
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Alcohol
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormCloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Professional Disposables International, Inc.
Labeler Code10819
FDA Application Number What is the FDA Application Number?
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.
part333A
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-01-2014
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Packages

NDC 10819-3916-1

Package Description: 100 PACKET in 1 BOX > .7 mL in 1 PACKET

Product Details

Pdi Sani-hands Instant Hand Sanitizing Wipes is a human over the counter drug product labeled by Professional Disposables International, Inc.. The generic name of Pdi Sani-hands Instant Hand Sanitizing Wipes is alcohol. The product's dosage form is cloth and is administered via topical form.


What are Pdi Sani-hands Instant Hand Sanitizing Wipes Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)


* Please review the disclaimer below.

Pdi Sani-hands Instant Hand Sanitizing Wipes Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Uses



  • Antiseptic
  • For hand washing to decrease bacteria on the skin; after assisting ill persons; and before contact with a person under medical care or treatment
  • Apply topically to the skin to help prevent cross-contamination
  • Recommended for repeated use.
  • Dries in seconds

Warnings



  • Flammable, keep away from fire or flame.
  • For external use only.
  • Do not use in or contact the eyes.
  • Discontinue use if irritation and redness develop. If condition persist for more than 72 hours consult a physician.
  • If swallowed, get medical help or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children unless under adult supervision.

Directions




  • Tear open packet.
  • Open and unfold towelette.
  • Wipe hands, fingers, interdigital areas and wrists thoroughly with towelettes. 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.

Other Information



Lot No. and Expiration Date can be found on packet.


Dosage



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.


Inactive Ingredients



Water, Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate


Other



Professional Disposables International, Inc.
Orangeburg, NY 10962

Made in USA


Principal Display Panel - 100 Packets Per Box



PDI Sani-Hands(R)
Instant Hand Sanitizing Wipes

  • Cleans and Sanitizes Hands
  • Kills 99.99% of Germs
  • Safe to Use Before Eating and Drinking
  • Contains Moisturizing Aloe and Vitamin E
  • Now contains 70% alcohol

    100 Wipes
    5.0 x 8.0 in (12.7 x 20.3 cm)

    #1 Hand Wipe in Healthcare

    Packet Label

    Box Label


Active Ingredient



Alcohol 70% by volume


Purpose



Antiseptic


* Please review the disclaimer below.