NDC 44019-007 Moist Wipes

Benzalkonium Chloride

NDC Product Code 44019-007

NDC 44019-007-02

Package Description: 20 PACKET in 1 BAG > .1 g in 1 PACKET (44019-007-01)

NDC Product Information

Moist Wipes with NDC 44019-007 is a a human over the counter drug product labeled by Yinjing Medical Technology (shanghai) Co., Ltd.. The generic name of Moist Wipes is benzalkonium chloride. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Yinjing Medical Technology (shanghai) Co., Ltd.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Moist 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 .1 g/100g

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)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PEG-54 HYDROGENATED CASTOR OIL (UNII: 0WZF1506N9)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYL SOYATE (UNII: 808DL597QP)

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: Yinjing Medical Technology (shanghai) Co., Ltd.
Labeler Code: 44019
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: 07-26-2016 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: 12-31-2020 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.

Moist Wipes Product Label Images

Moist 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

Otc - Active Ingredient

Active ingredientBenzalkonium chloride 0.115%

Otc - Purpose

PurposeAntibacterial

Indications & Usage

Use   decreases bacteria on skin

Warnings

WarningsFor external use onlyDo not use-over large areas of the body if you are allergic to any of the ingredientsWhen using this product avoid contact with eyes and face.If contact occurs, flush thoroughly with water.Stop use and ask a doctor if irritation or rash develops andcontinues for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Dosage & Administration

Directions-for adults and children of 2 years and over useon hands and face to clean and refresh, allow skin to air dry.-For children under 2 years ask a doctor before using

Inactive Ingredient

Inactive ingredientWater, propylene glycol, glycerin, cocamidopropylbetaine, polyaminopropyl biguanide, aloe barbadensis leaf extract, tocopheryl acetate, peg-54 hydrigenated castor oil, disodium edta,citric acid, fragrance, methylchloroisothiazolinone, methylsothiazolinone

* Please review the disclaimer below.