ZILACTIN-B (BENZOCAINE) GEL [BLAIREX LABORATORIES, INC.]

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ZILACTIN-B (BENZOCAINE) GEL [BLAIREX LABORATORIES, INC.]
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NDC 50486-550-32
Set ID 34ce5d91-35ff-4f2c-9d6b-ac389895b6b2
Category HUMAN OTC DRUG LABEL
Packager Blairex Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART346
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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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