FDA.reportPublic FDA data

CurX Antimicrobial Gel

Manufacturer
Global Health Solutions, LLC
Effective date
2015-10-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:44:03

Label at a glance#

ProductCurX Antimicrobial Gel
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

first aid to to help treat, protect and prevent skin infection associated with minor cuts scrapes burns

Dosage and administration

adults and children 2 years and older: clean the affected area; apply a small amount on the area 1-3 times daily;may be covered with a sterile bandage (let dry first) children under 2 years: ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Ch. 0.13% (i/s*)

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

first aid to to help treat, protect and prevent skin infection associated with

  • minor cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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: clean the affected area; apply a small amount on the area 1-3 times daily;may be covered with a sterile bandage (let dry first)
  • children under 2 years: ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

Avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

USP Petrolatum, Water, Polihexanide (PHMB)

Questions?

OTC - QUESTIONS SECTION

1-706-844-1025

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GLOBAL HEALTH SOLUTIONS, LLC

CurXTM Antimicrobial Gel

First Aid Antimicrobial Gel

Hospital and Professional Use Only

Non-Antibiotic

45 g

CurX is a registered trademark of Global Health Solutions

untitled.jpguntitled.jpg

*Microdroplet Suspension Technology

SPL UNCLASSIFIED SECTION

*Proprietary microdroplet suspension technology. Percentage reflective of active ingredient bioavailability in solution.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098199benzalkonium chloride 0.13 % Topical GelPSN2
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCD2
1098199benzalkonium chloride 0.13 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69578-466-452020-01-31C16284748780-19d75b9cf-cfdd-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69578-466-45CurX Antimicrobial Gel45 g in 1 TUBEGEL452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69578-466CURX ANTIMICROBIAL GEL (BENZALKONIUM CHLORIDE) GEL [GLOBAL HEALTH SOLUTIONS, LLC]2Legacy NDC, 1 package rows20151113_03ea1784-cc43-4b6f-82a2-680296340fbd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W72
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U2
POLIHEXANIDEINACTIVE INGREDIENT322U039GMF2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69578-46669578-466-45

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
POLIHEXANIDE322U039GMFIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates

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
a76170c6-a407-45d4-b461-424bf04b573603ea1784-cc43-4b6f-82a2-680296340fbd2015-10-28WarningsExact identifier
spl id: a76170c6-a407-45d4-b461-424bf04b5736
spl set id: 03ea1784-cc43-4b6f-82a2-680296340fbd

Reported adverse events (FAERS/openFDA)#

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