NDC 78833-010 Disinfectant Wipes

Benzalkonium Chloride/ Isopropyl Alcohol

NDC Product Code 78833-010

NDC 78833-010-01

Package Description: 480 mL in 1 CYLINDER

NDC Product Information

Disinfectant Wipes with NDC 78833-010 is a a human over the counter drug product labeled by Mb Diversity. The generic name of Disinfectant Wipes is benzalkonium chloride/ isopropyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Mb Diversity

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.

Disinfectant 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.

  • ISOPROPYL ALCOHOL 4 mL/100mL
  • BENZALKONIUM CHLORIDE .5 mg/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.

  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • CITRONELLAL (UNII: QB99VZZ7GZ)
  • .ALPHA.-PINENE (UNII: JPF3YI7O34)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • LINALYL ACETATE (UNII: 5K47SSQ51G)
  • MYRCENE (UNII: 3M39CZS25B)
  • LIMONENE DIEPOXIDE (UNII: M6TUW5WEJ9)
  • 2-METHOXY-1-PROPANOL (UNII: 18B570XOYF)
  • CITRAL (UNII: T7EU0O9VPP)
  • 4-METHYL-1,4-PENTANEDIYL DIMETHACRYLATE (UNII: 3BHT04VYO9)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • LAURETH-9 PHOSPHATE (UNII: 0N8G76HI1O)
  • .BETA.-PINENE (UNII: 4MS8VHZ1HJ)
  • TERPINOLENE (UNII: N9830X5KSL)

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: Mb Diversity
Labeler Code: 78833
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: 07-08-2020 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.

Disinfectant Wipes Product Label Images

Disinfectant 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 Monograph Not Final

This is a disinfectant wipe manufacturered according to the FDA Monograph Not Final, regarding Benzalkonium Chloride as a disinfectant, which may be used to battle COVID-19. It has proven effective at destroying coronavirus' envelopes, and many other biocide functions for years. We chose a solution of 0.50% BZK concentration to prevent any topical skin irritation, which has been documented at levels of ≥1% concentrations. We also advise anyone with skin conditions to wear gloves, or any Respiratory problems to use a sufficient Respirator, such as an N-95, because inhalation of BZK has shown complications with individuals who have severe asthma or other Respiratory Problems. We also advise rinsing disinfected surfaces with potable water before placing food on them, to prevent any unwanted ingestions of the BKS.BKC formulation kills 99.99% of most bacteria, and also influenza as well as molds.Less than a year ago, the Food and Drug Administration went even further, green-lighting the over-the-counter sale of BZK-manufactured hand hygiene products.

Active Ingredient(S)

Benzalkonium Chloride 0.5% v/v. Purpose AntisepticAlcohol 4% v/v. Purpose: Antiseptic, Necessary to Dilluted BKC

Purpose

Antiseptic, Multi Surface Disinfectant, and Topical Antiseptic

Use

Multi-surface and topical Disinfectant wipe to help reduce bacteria that potentially can cause disease.For use on Non-Porous surfaces to aid in disinfecting.Recommended for repeated use.

Do Not Use

  • If you have Respiratory problems.On open skin wounds.If you suffer from dermatitis, psoriasis, excema.

When Using This Product

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water. Avoid contact with broken skin. Do not inhale fumes or ingest.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.Avoid use on untreated wood or porous surfaces.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions

  • Wipe generously on non porous surfaces to completely cover. Wipe until clean, allow to remain visibly wet until surfaces air dry.After disinfecting, thoroughly rinse surfaces, with potable water, before coming into direct contact with food.Children under 6 years of age should not be using this product.Throw away soiled wipes, do not reuse.Dispose of wipes in the trash, do not throw into the toilet.Avoid eye contact, or swallowing.

Other Information

  • Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Laureth-9 Phosphate, Glycerin, DMDM Hydantoin, Fragrance, RO Water USP

Recent Major Changes

Drug FactsActive IngredientPurposeBenzalkonium Chloride 0.50%v/v...........................................Antiseptic, Surface WipeIsopropyl Alcohol 4% v/v…………………..………….. Antiseptic, Properly Dilutes BKCUsesDisinfectant wipe to help reduce bacteria that potentially can cause disease.For use on Non-Porous surfaces to aid in disinfecting.Recommended for repeated use.WarningsFor multipurpose surface disinfectant or external use only - if you have sensitive skin, use gloves for prolonged exposure to protect hands. People with skin conditions of open wounds should avoid direct contact. Asthmatics or people with respiratory problems should use a respirator to avoid inhaling fumes.Flammable. Keep away from heat or flame.Do not useIf you have Respiratory problems.On open skin wounds.If you suffer from dermatitis, psoriasis, excemaWhen using this productKeep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.Avoid contact with broken skin.Do not inhale fumes or ingest.Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.Avoid use on untreated wood or porous surfaces.Stop use and ask a doctor if a rash or skin irritation occurs. These may be signs of a serious condition.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.DirectionsWipe generously on non porous surfaces to completely cover.Wipe until clean, allow to remain visibly wet until surfaces air dry.After disinfecting, thoroughly rinse surfaces, with potable water, before coming into direct contact with food.Children under 6 years of age should not be using this product.Throw away soiled wipes, do not reuse.Dispose of wipes in the trash, do not throw into the toilet.Avoid eye contact, or swallowing.Other InformationAvoid freezing and excessive heat above 104°FStore between 59°-86°FMay discolor some fabricsHarmful to untreated wood, some plastics, untreated grout.Inactive IngredientsLaureth-9 Phosphate, Glycerin, DMDM Hydantoin, Fragrance, RO Water USP

* Please review the disclaimer below.