Globe Antiseptic Spray

Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Effective date
2024-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:06

Label at a glance#

ProductAntiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Clean affected area and spray 1 to 3 times daily May be covered wiht a sterile bandage Not to be used on children under 12 years of age

Storage and handling

Store at controlled room temperature 68º-77ºF (20º-25ºC)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride .13%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

INDICATIONS & USAGE SECTION

First Aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings

WARNINGS SECTION

For External Use Only

Flammable. Keep away from fire or flame.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If the condition persists or gets worse.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean affected area and spray 1 to 3 times daily
  • May be covered wiht a sterile bandage
  • Not to be used on children under 12 years of age

Do Not Use

OTC - DO NOT USE SECTION

  • Near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or serious burns
  • over large areas of the body
  • for more than one week unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 68º-77ºF (20º-25ºC)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, alcohol

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Distributed By:

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 4069-FBA

Made in China

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4080 GLOBE ANTISEPTIC SPRAY 2OZ LOOSE 030824 CDER4080 GLOBE ANTISEPTIC SPRAY 2OZ LOOSE 030824 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039012benzalkonium chloride 0.13 % Topical SprayPSN1
1039012benzalkonium chloride 1.3 MG/ML Topical SpraySCD1
1039012benzalkonium chloride 0.13 % Topical SpraySY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-153-02Antiseptic0.0591 L in 1 BOTTLE, SPRAYSPRAY0.05911

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-153ANTISEPTIC (BENZALKONIUM CHLORIDE 0.13%) SPRAY [TRIFECTA PHARMACEUTICALS USA, LLC.]1Current NDC, 1 package rows20240322_13f1c70f-3b44-8eef-e063-6294a90af634.zip

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
69396-15369396-153-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALCOHOL3K9958V90MIACT

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
AntisepticBENZALKONIUM CHLORIDE 0.13%Trifecta Pharmaceuticals USA, LLC.13f1c70f-3b44-8eef-e063-6294a90af6342024-03-18WarningsExact identifier
ndc (package): 69396-153-02
ndc (product): 69396-153
ndc11 (package): 69396015302
spl id: 13f1a05a-30a4-34da-e063-6394a90a8b6a
spl set id: 13f1c70f-3b44-8eef-e063-6294a90af634

Reported adverse events (FAERS/openFDA)#

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