Label: TRICLARA- benzalkonium chloride liquid

  • NDC Code(s): 72518-001-00
  • Packager: Nightingale Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride (0.13%)

  • PURPOSE

    Purpose

    Antiseptic - First Aid

  • INDICATIONS & USAGE

    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

    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.

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    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

    Inactive ingredients

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

  • 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 label

    drug facts panel

  • INGREDIENTS AND APPEARANCE
    TRICLARA 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72518-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72518-001-003.5 g in 1 BOTTLE; Type 0: Not a Combination Product05/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)05/14/2019
    Labeler - Nightingale Pharmaceuticals, Inc. (081338827)
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