NDC 69578-268 Hexagen

Skin And Nasal Antiseptic

NDC Product Code 69578-268

NDC 69578-268-30

Package Description: 30 g in 1 CARTON

NDC Product Information

Hexagen with NDC 69578-268 is a a human over the counter drug product labeled by Global Health Solutions Dba Turn Therapeutics. The generic name of Hexagen is skin and nasal antiseptic. The product's dosage form is liquid and is administered via nasal; topical form.

Labeler Name: Global Health Solutions Dba Turn Therapeutics

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.

Hexagen 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 .13 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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • WATER (UNII: 059QF0KO0R)
  • POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Nasal - Administration to the nose; administered by way of the nose.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Nasal - Administration to the nose; administered by way of the nose.
  • 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: Global Health Solutions Dba Turn Therapeutics
Labeler Code: 69578
FDA Application Number: part333E 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: 07-14-2020 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.

Hexagen Product Label Images

Hexagen 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 (0.13% i/s*)

Purpose

Antiseptic

Uses

  • Help reduce pathogens that potentiallu can cause infections.May be used to prepare skin prior to surgery.

Warnings

Do not ingestAsk a doctor before use if you have Signs of an existing infection

When Using This Product

  • Do not use in or near the eyes.Do not use if you have a history of allergy to any of the ingredients.Do no use concurrently with other products on the same application site.

Stop Use And Ask A Doctor

  • If condition worsensSymptoms persist for more than 7 days, or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children 2 years and older:Skin ApplicationGently clean the affected areaApply a small amount 1-3 times dailyMay be covered with a sterile bandageNasal ApplicationGently clean the affected areaApply a small amount onto a sterile swab and insert into the nostrilRemove swabPress outside of nostril to facilitate transfer of ointment throughoutRepeat process for other nostril with a new, sterile swabDo not blow noseAvoid touching the area inside and around the nostrilsMay be used up to 2-3 times per dayChildren under 2 years:Ask a doctor

Other Information

Avoid excessive heat.

Inactive Ingredients

USP Petrolatum, Purified Water, PHMB (antimicrobial preservative)

Questions?

818-546-4011

Other

*Proprietary nanodroplet suspension technology. Percentage reflective of active ingredient bioactivity in solution.

Hexagen

Skin and Nasal AntisepticPrescription Strength Formula Now Available Over the CounterPetrolatum-Based, Non-Cytotoxic, Extended-Wear NET WT: 30 gMade in USAManufactured in the USAwww.hexagen.us
Turn Therapeutics
Calabasas, CADocumented protection against:MRSA, Staphylococcus Aureus, Candid Auris, Human Coronavirus, Candid Albicans, PseudomonasAntiviral, Antibacterial, Antifungal

* Please review the disclaimer below.