Hexagen

Manufacturer
Global Health Solutions DBA Turn Therapeutics
Effective date
2020-07-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:15:37

Label at a glance#

ProductHexagen
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Indications and uses

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

Dosage and administration

Adults and children 2 years and older: Skin Application Gently clean the affected area Apply a small amount 1-3 times daily May be covered with a sterile bandage Nasal Application Gently clean the affected area Apply a small amount onto a sterile swab and insert into the nostril Remove swab Press outside of nostril to facilitate transfer of ointment throughout Repeat process for other nostril with a new, sterile s...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride (0.13% i/s*)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not ingest

Ask a doctor before use if you have Signs of an existing infection

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older:

Skin Application

  • Gently clean the affected area
  • Apply a small amount 1-3 times daily
  • May be covered with a sterile bandage

Nasal Application

  • Gently clean the affected area
  • Apply a small amount onto a sterile swab and insert into the nostril
  • Remove swab
  • Press outside of nostril to facilitate transfer of ointment throughout
  • Repeat process for other nostril with a new, sterile swab
  • Do not blow nose
  • Avoid touching the area inside and around the nostrils
  • May be used up to 2-3 times per day

Children under 2 years:

  • Ask a doctor

Other Information

OTHER SAFETY INFORMATION

Avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

USP Petrolatum, Purified Water, PHMB (antimicrobial preservative)

Questions?

OTC - QUESTIONS SECTION

818-546-4011

SPL UNCLASSIFIED SECTION

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

HEXAGEN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Skin and Nasal Antiseptic

Prescription Strength Formula Now Available Over the Counter

Petrolatum-Based, Non-Cytotoxic, Extended-Wear NET WT: 30 g

Made in USA

Manufactured in the USA

www.hexagen.us


Turn Therapeutics

Calabasas, CA

Documented protection against:

MRSA, Staphylococcus Aureus, Candida Auris, Human Coronavirus, Candida Albicans, Pseudomonas

Antiviral, Antibacterial, Antifungal

Unit CartonUnit Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69578-268-302022-11-10C16284748780-1d6a99b39-952c-a426-e053-dadaa90af4c2Hexagen Skin and Nasal Antiseptic
69578-268-302022-01-28C16284748780-1d6a99b39-952c-a426-e053-dadaa90af4c2Hexagen Skin and Nasal Antiseptic

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69578-26869578-268-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ed1685bb-4521-5cbf-e053-2995a90aba31aa6eef2d-d752-2117-e053-2995a90aff4f2022-11-09WarningsExact identifier
spl set id: aa6eef2d-d752-2117-e053-2995a90aff4f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.