FDA.reportPublic FDA data

TriClara

Manufacturer
Nightingale Pharmaceuticals, Inc.
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:43:51

Label at a glance#

ProductTriClara
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Benzalkonium Chloride (0.13%)

OTC - PURPOSE SECTION

Purpose

Antiseptic - First Aid

INDICATIONS & USAGE SECTION

Uses

  • treatment of cold sore / fever blister
  • effective relief of symptoms of cold sore / fever blister
  • protects against infections in sores, burns, cuts and scrapes

WARNINGS SECTION

Warnings

  • For external use only: Do not use in or around eyes or ears. Consult a physician before using on puncture wounds, serious burns or animal bites.
  • Allergy alert: Do not use if you are allergic to any ingredients in this product.

OTC - STOP USE SECTION

Stop use and consult a doctor if the condition persists or gets worse.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact poison control at 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

Directions

  • clean the affected area with soap and water and thoroughly dry the area.
  • for best results apply a small quantity with a rubbing motion 8 times (once every 2 hours while awake) daily at onset of symptoms until cleared.
  • wash hands after applying.
  • do not share this product with others.
  • retain these directions for help with use.
  • for use on children under 12 years: ask a doctor.

OTHER SAFETY INFORMATION

Other information

  • Store at 15 to 25°C (59 to 77°F), in a dry place, away from heat, humidity and direct sunlight
  • Discard 30 days after removeal from vauumed pouch.

INACTIVE INGREDIENT SECTION

Inactive ingredients

glycerin, water, N-acetyl cysteine, sodium hydroxide (for pH), ascorbic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TriClara ® ON & GONE

New

Antiseptic Cold Sore Treatment

0.13% Benzalkonium Chloride

FAST

CLEAR

EFFECTIVE

BETTER APPEARANCE + SOOTHING RELIEF

Cold Sore / Fever Blister Antiseptic

NET WT 3.5G / .12 OZ

Distributed by:

Nightingale Pharmaceuticals, Inc.

Santee, CA 92071

www.triclara.com

RETAIN CARTON FOR COMPLETE PRODUCT INFORMAITON

front labelfront label

drug facts paneldrug facts panel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72518-001TRICLARA (BENZALKONIUM CHLORIDE) LIQUID [NIGHTINGALE PHARMACEUTICALS, INC.]4Legacy NDC20250101_80266ad5-45de-e3a4-e053-2a91aa0a0c94.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72518-00172518-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ACETYLCYSTEINEWYQ7N0BPYCIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML · Source PDF

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
4740efaa-4024-f9a8-e063-6294a90a09fb80266ad5-45de-e3a4-e053-2a91aa0a0c942025-12-31WarningsExact identifier
spl set id: 80266ad5-45de-e3a4-e053-2a91aa0a0c94

Reported adverse events (FAERS/openFDA)#

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