Label: ZILACTIN-B- benzocaine gel

  • NDC Code(s): 50486-550-32
  • Packager: Blairex Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 23, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzocaine 10%

  • Purpose

    Oral pain reliever

  • Use

    temporarily relieves pain caused by:

    • canker sores
    • minor mouth sores and gum irritations
    • denture and brace pain
  • Warnings

    Flammable:

    • keep away from fire or flame

    Allergy Alert:

    • do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics

    Stop use and ask a physician if

    • sore mouth symptoms do not improve in 7 days
    • swelling, rash or fever develops
    • irritation, pain or redness persists or worsens
    • apply only to affected area
    • do not exceed recommended dosage
    • avoid contact with the eyes
    • do not use for more than 7 days unless directed by a physician or dentist

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

  • Directions

    adults and children
    2 years and older     		Dry affected area. Apply a thin coat of gel with cotton swab or clean finger up to 4 times daily. Allow to dry 30-60 seconds.
    children under 12 years adult supervision should be given in the use of this product
    children under 2 years do not use, consult a physician or dentist
  • Other information

    • do not peel off protective film. Attempting to peel off film may result in skin irritation or tenderness. To remove film, first apply another coat of Zilactin-B Long Lasting Mouth Sore Gel to film, and immediately wipe the area with a moist gauze pad or tissue.
    • contains alcohol 65% by volume
    • store at 15-30°C (59-86°F)
  • Inactive ingredients

    Boric acid, hydroxypropylcellulose, propylene glycol, purified water, salicylic acid, SD alcohol 38-B, tannic acid

    Manufactured for: Blairex Laboratories, Inc. P.O. Box 2127 Columbus, IN 47202 USA

  • QUESTIONS

    Telephone Questions or Comments?
    Call TOLL FREE 1-800-252-4739
    www.zilactin.com

  • PRINCIPAL DISPLAY PANEL

    PROMOTES HEALING

    Oral Pain Reliever

    Zilactin ®-B 6 Hour Canker & Mouth Sore Relief

    • Bioadhesive Promotes Healing
    • Eat and Drink Pain-Free for up to 6 Hours

    Net wt. 0.25 oz (7g)

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ZILACTIN-B 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50486-550
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TANNIC ACID (UNII: 28F9E0DJY6)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50486-550-321 in 1 CARTON06/29/2005
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/29/2005
    Labeler - Blairex Laboratories, Inc. (092575133)
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