MARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]

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MARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]
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NDC 61509-101-32
Set ID 63f55e58-7036-4325-91f2-dc3681684373
Category HUMAN OTC DRUG LABEL
Packager Cargus International, Inc.
Generic Name
Product Class
Product Number
Application Number PART356
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  • Active Ingredient

    Benzocaine, 20%

  • Purpose

    Oral Anesthetic

  • Uses

    For the temporary relief of pain associated with canker sores and minor dental procedures.

  • Warnings

    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.

    Do not

    use this product for more than 7 days unless directed by a dentist or doctor.  If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly

    Do not

    exceed recommended dosage.

  • Keep out of reach of children.

    If more than used for pain is accidentially swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older: Apply to the affected area.  Use up to 4 times daily or as directed by a dentist or doctor
    • Children under 12 years of age should be supervised in the use of the product.
    • Children under 2 years of age: Consult a dentist or doctor.
  • Other Information

    Store at room temperature 59 - 86°F (15 - 30°C).  Protect from freezing and heat.

  • Inactive Ingredients

    FD&C Red No. 40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol

  • Distributed by

    Mark 3, 135 North Rt. 9W, Congers, NY 10920

    1.888.732.2913

  • PRINCIPAL DISPLAY PANEL

    Mark 3

    Oral Anesthetic Gel

    Cherry

    Gluten Free

    with Vitamin E and Xylitol

    NDC 61509-101-32

    Net Wt. 1.12 oz. (32 g)

    Distributed by Mark 3, 135 North Rt. 9W, Congers, NY 10920

    Made in USA

    20140228 101 Benzocaine Cherry

  • INGREDIENTS AND APPEARANCE
    MARK 3 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61509-101
    Route of AdministrationORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6.4 g  in 32 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61509-101-3232 g in 1 BOTTLE; Type 0: Not a Combination Product03/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/28/2014
    Labeler - Cargus International, Inc. (096191093)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dharma Research, Inc.078444642manufacture(61509-101)
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