NDC 71315-800 Mediseptic Antinfectant

Benzalkonium Chloride

NDC Product Code 71315-800

NDC 71315-800-01

Package Description: 10 g in 1 BOTTLE, SPRAY

NDC 71315-800-05

Package Description: 50 g in 1 BOTTLE, PUMP

NDC 71315-800-10

Package Description: 100 g in 1 BOTTLE, PLASTIC

NDC 71315-800-25

Package Description: 250 g in 1 BOTTLE, PLASTIC

NDC 71315-800-50

Package Description: 500 g in 1 BOTTLE, PLASTIC

NDC Product Information

Mediseptic Antinfectant with NDC 71315-800 is a a human over the counter drug product labeled by Katan Technologies Usa, Llc. The generic name of Mediseptic Antinfectant is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Katan Technologies Usa, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Mediseptic Antinfectant 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.

  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • POVIDONE K15 (UNII: E54VE15114)
  • CALCIUM FLUORIDE (UNII: O3B55K4YKI)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 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: Katan Technologies Usa, Llc
Labeler Code: 71315
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: 05-01-2020 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.

Mediseptic Antinfectant Product Label Images

Mediseptic Antinfectant 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

Mediseptic

Application:Apply approx. 3-5ml of undiluted product into hollow hands and rub in. In particular take into account thumbs and fingertips, as they have most frequent contact with contaminated surfaces and objects.Frequency: Repeat as needed, to renew two hour long term protection.Application time: 1 minute

Inactive Ingredients:WaterMineral saltsOrganic acidsOrganic saltsGlycerin

Use:Hygienic hand disinfectionUse disinfectant safely. Always read label and product information before use.

Active Ingredient:Benzalkonium chloride ....0.1% ............antibacterial

Safety information:• Keep out of reach of children.

WarningsFor external use only.Keep out of reach of children.Not for food use.Do not ingest.

• Keep out of reach of children.• Do not mix with acids and alkalis.• Store below 30C/86F.• Dispose of empty container in accordance with local regulations.• Safety data sheet available upon request.• Keep container tightly closed after use and keep cool.

Otc - Purpose

Purpose:antimicrobialfor hand disinfection

Mediseptic Anitinfectant

MediSepticprotect yourself everydayAnti Infection Sprayfor hygienic hand disinfection in accordance with DIN EN 1500120 Min. Long-Term Efficacy• Continuous protection for 2 hours• Proven efficacy against bacteria and viruses (99.999%)• Skin-friendly and alcohol-freeUse:Hygienic hand disinfectionApplication:Apply approx. 3-5ml of undiluted product into hollow hands and rub in. In particular take into account thumbs and fingertips, as they have the most frequent contact with contaminated surfaces and objects.Frequency: Repeat as needed, to renew two-hour long term protection.Application time: 1 minuteSafety information:• Keep out of reach of children.• Do not mix with acids ans alkalis.• Store below 30C/86F.• Dispose of empty container in accordance with local regulations.• Safety data sheet available upon request.• Keep container tightly closed after use and keep cool.Non-hazardous substance according to CLP-regulationAlcohol-freeNon-toxicWithout surfactants and aldehydesNon-flammableUse disinfectant safely. Always read label and product information before use.

* Please review the disclaimer below.