Label: MARK 3- benzocaine gel

  • 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 March 23, 2021

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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

    Strawberry

    Gluten Free

    with Vitamin E and Xylitol

    NDC 61509-103-32

    Net Wt. 1.12 oz. (32 g)

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

    Made in USA

    20140228 103 Strawberry

  • INGREDIENTS AND APPEARANCE
    MARK 3 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61509-103
    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
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61509-103-3232 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(61509-103)
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