NDC 10819-7009 Sani Professional Brand Sani-hands For Kidshand Wipes Hand Wipes

Benzalkonium Chloride

NDC Product Code 10819-7009

NDC CODE: 10819-7009

Proprietary Name: Sani Professional Brand Sani-hands For Kidshand Wipes Hand Wipes 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.

Non-Proprietary Name: Benzalkonium Chloride 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.

NDC Code Structure

  • 10819 - Professional Disposables International, Inc.
    • 10819-7009 - Sani Professional Brand Sani-hands For Kidshand Wipes

NDC 10819-7009-3

Package Description: 6 CONTAINER in 1 CASE > 933 mL in 1 CONTAINER

NDC Product Information

Sani Professional Brand Sani-hands For Kidshand Wipes Hand Wipes with NDC 10819-7009 is a a human over the counter drug product labeled by Professional Disposables International, Inc.. The generic name of Sani Professional Brand Sani-hands For Kidshand Wipes Hand Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Professional Disposables International, Inc.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

Product Type: Human Otc Drug 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.

Sani Professional Brand Sani-hands For Kidshand Wipes Hand Wipes Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZALKONIUM CHLORIDE .13 mg/mL

Inactive Ingredient(s)

About the 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)
  • ALCOHOL (UNII: 3K9958V90M)
  • SORBIC ACID (UNII: X045WJ989B)
  • PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • MICROCITRUS AUSTRALIS FRUIT (UNII: 9DNS80T428)

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.

Labeler Name: Professional Disposables International, Inc.
Labeler Code: 10819
FDA Application Number: part333A 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 01-01-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sani Professional Brand Sani-hands For Kidshand Wipes Hand Wipes Product Label Images

Sani Professional Brand Sani-hands For Kidshand Wipes Hand Wipes Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Use

For hand washing to decrease bacteria on the skin

Warnings

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

Otc - Keep Out Of Reach Of Children

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

Directions

  • To start feed: Remove cover and discard seal from container. From center of wipe 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 90 degree  angle. Keep center cap closed to prevent moisture loss. Wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. Be sure to utilize the entire wipe surface. Allow to dry.For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with second wipe.Discard after single use.

Other Information

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

Dosage

Wipe hands, fingers, interdigital areas and wrists thouroughly with towelette. Be sure to utilize the entire wipe surface. Allow to dry.

Inactive Ingredients

Water, SD Alcohol 40, Sorbic Acid, PPG-2 Hydroxyethyl Cocamide, Disodium EDTA, Aloe Barbadensis Leaf Juice, Fragrance

Other

Professional Disposables International, Inc.Orangeburg, NY 10962-1376 - USA -1-866-673-4376www.wipeyourwoldclean.com

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antiseptic handwash

* Please review the disclaimer below.