NDC 72619-0820 Hand Wipes

Hand Wipes

NDC Product Code 72619-0820

NDC 72619-0820-1

Package Description: 30 CANISTER in 1 CANISTER > 4 mL in 1 CANISTER

NDC Product Information

Hand Wipes with NDC 72619-0820 is a a human over the counter drug product labeled by Accessory Myxx Llc. The generic name of Hand Wipes is hand wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Accessory Myxx Llc

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.

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 g/100mL

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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)

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.
  • 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: Accessory Myxx Llc
Labeler Code: 72619
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: 08-28-2020 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.

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

Dosage & Administration

Recommended for repeated use.

Warnings

For external use only. Do not use over large areas of the body or if you are allergic to any of these ingredients.

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredient

Water, Phenoxyethanol, Ethylhexylglycerin, Didecyldimonium Chloride , Propylene Glycol, Glycerin

Indications & Usage

Lift tab at front of the lid t o open.

Pull up corner of center sheet and thread

through di spenser slit i n the l id.

Pull up exposed wipe and snap off.

The next wipe i s ready for dispensing.

Close lid t o retain moisture.
Take wipe and rub thoroughly over all

surfaces of bot h hands. Rub hands briskly

together to dry.

Dispose of used wipe in trash.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Purpose

For Hand Sanitizing to decrease bacteria on the skin. Recommended for repeated use.

Otc - Active Ingredient

Benzalkonium Chloride

* Please review the disclaimer below.