NDC 79680-008 Lifeguard Disinfecting Wipes

Benzalkonium Chloride

NDC Product Code 79680-008

NDC 79680-008-01

Package Description: 100 POUCH in 1 CANISTER > 3.5 g in 1 POUCH

NDC Product Information

Lifeguard Disinfecting Wipes with NDC 79680-008 is a a human over the counter drug product labeled by Zhejiang Saiveroy Cleaning Products Co., Ltd.. The generic name of Lifeguard Disinfecting Wipes is benzalkonium chloride. The product's dosage form is swab and is administered via topical form.

Labeler Name: Zhejiang Saiveroy Cleaning Products 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 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.

Lifeguard Disinfecting 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)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: Zhejiang Saiveroy Cleaning Products Co., Ltd.
Labeler Code: 79680
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: 12-07-2020 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.

Lifeguard Disinfecting Wipes Product Label Images

Lifeguard Disinfecting 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

Active Ingredient

Benzalkonium Chloride 0.10%

Purpose

Antiseptic

Use

Signle use wipes to clean.

Warning

  • General Advice: show this safety data sheet to the doctor in the attendance.Eye contact: Hold eye open and rinse slowly and gently with water for 15-20 minutes. If preset, remove contact lenses after a poison control center or doctor for further treatment advice.Skin Contact: Rinse skin with plenty of water. If irritation persists, call a doctor.Inhalation: Move a fresh air. If breathing problems develop, call a doctor.Ingestion: Drink a glassful of water. Call a doctor or poison control center.

Otc - Keep Out Of Reach Of Children

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

Directions For Use; Instruction, Storage And Disposal

Directions for use:It is a violation of Federal law to use this product in a manner inconsistent with labeling. Not for cleaning or sanitizing skin. Do not use as a diaper wipe or for personal cleansing.Instructions:Before using, open the tab, then take the wipe and pass it through the hole of the bag. wipe the surface and allow one minute contact time.Storage and Disposal:Dispose of wipe in the trash after use. Tightly close seal between uses to retain moisture. Please empty container for recycling. If recycling not available, discard container in trash.

Inactive Ingredients

Aqua, Phenoxyethanol, Ethylhexylglycerin, Propylene Glycol, Aloe Barbadensis Leaf Extract.

* Please review the disclaimer below.