NDC 76635-002 Goldessence Disinfecting Wipes

Benzalkonium Chloride

NDC Product Code 76635-002

NDC 76635-002-01

Package Description: 322 g in 1 BAG

NDC Product Information

Goldessence Disinfecting Wipes with NDC 76635-002 is a a human over the counter drug product labeled by Hangzhou Glamcos Biotech Co.,ltd. The generic name of Goldessence Disinfecting Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Hangzhou Glamcos Biotech Co.,ltd

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.

Goldessence 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 .3 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.

  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
  • FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)

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: Hangzhou Glamcos Biotech Co.,ltd
Labeler Code: 76635
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: 04-30-2020 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.

Goldessence Disinfecting Wipes Product Label Images

Goldessence 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(S)

Benzalkonium Chloride 0.3%

Purpose

Antiseptic

Use

To clean and decrease bacteria and germs on skin and surfaces.

Warnings

Keep container tightly sealed,avoid contact with eyes ,wash hands after handing,not for use on broken or sensitive skin,stop use if skin irritation develops,flush eyes immediately if product enters eyes.Keep away from heat and flame.Call a poison control center or doctor for treatment advice.Have the product container label with you when calling a poison control center or doctor,or going for treatment.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children and pets.

Directions

Remove cover.Pull up wipe corner from center of roll.Thread through hole in the cover.Replace cover. Open center cap on cover to remove wipe. When not using,close center cap securely to prevent moisture loss.

Unfold wipe to wipe down surface or hands.Dispose wipe after each use.Let air dry.If surfaces are extremely dirty,clean first with another wipe before disinfecting.

Other Information

Do not flush.

Rinse toys or food with clean water after disinfecting.

Do not use as a diaper wipe or on sensitive skin.

Do not use on unpainted wood.

Do not use to disinfect dishes,glassware or utensils.

Storage and disposal: Store in original container in areas inaccessible to children.Keep securely closed.Do not reuse or refill this container.Discard empty container in trash or recycle.
Perfect to wipe away tough messes while leaving a refreshing scent behind. Our disinfecting wipes get rid of dirt and grime on hand,arms,legs,and most surfaces in your home or office while wiping away 99.9% of germs and bacteria. Formulated to be gentle on skin without alcohol,dyes,parabens or harsh chemicals,they can be used safely on your skin and most washable non-porous surfaces such as bathroom fixtures,countertops,doorknobs,electronics and appliances. Thoroughly clean and disinfect by wiping areas until visibly wet,allow to remain wet for 10 minutes,then air dry. Keep a container of wipes in your closet for daily household messes,keep some in your car for emergency clean up and when washning your hands with soap and water is not an option.

Inactive Ingredients

Water,Phenoxyethanol ,Propylene Glycol, Chlorphenesin,Didecyldimonium Chloride,Parfum(Fragrance)

* Please review the disclaimer below.