NDC 70897-005 Bzk Antiseptic Towelette

Benzalkonium Chloride

NDC Product Code 70897-005

NDC Code: 70897-005

Proprietary Name: Bzk Antiseptic Towelette Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 70897 - Davemed Healthcare Co., Ltd
    • 70897-005 - Bzk Antiseptic Towelette

NDC 70897-005-01

Package Description: 1 SWAB in 1 POUCH

NDC Product Information

Bzk Antiseptic Towelette with NDC 70897-005 is a a human over the counter drug product labeled by Davemed Healthcare Co., Ltd. The generic name of Bzk Antiseptic Towelette is benzalkonium chloride. The product's dosage form is swab and is administered via topical form.

Labeler Name: Davemed Healthcare Co., Ltd

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Bzk Antiseptic Towelette Active Ingredient(s)

Additional informationCallout TooltipWhat 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 .0013 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Davemed Healthcare Co., Ltd
Labeler Code: 70897
FDA Application Number: part333A Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-24-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Bzk Antiseptic Towelette Product Label Images

Bzk Antiseptic Towelette 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

Active Ingredients

Benzalkonium Chloride 0.13% v/v

Purpose

Antiseptic

Use

  • First aid antiseptic to help prevent skin infection in minor cutsscrapes, burns, anitiseptic cleansingperineal and maternity care

Warnings

  • For external use only
  • Do not use:
  • As an antiseptic for more than 1 weekin the eyes over large areas of the bodyAsk a doctor before use if you have deep or puncture woundsanimal bitesserious burnsStop useif irritation and redness developif condition persists more than 72 hours, consult a physician

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.

Directions

  • Tear at notch Remove toweletteUse only onceAs a first aid antisepticclean affected areaapply 1 to 3 times dailymay be covered with a sterile bandageif bandaged, let dry first

Inactive Ingredient

Water

Other Safety Information

  • Store at room temperature Avoid excessive heat

* Please review the disclaimer below.

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