Label: BENZODENT- benzocaine cream

  • NDC Code(s): 71687-1053-1, 71687-1053-2
  • Packager: Focus Consumer Healthcare, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 12, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Benzocaine 20%

  • PURPOSE

    Pain reliever

  • INDICATIONS & USAGE

    For the temporary relief of pain due to minor irritation of the mouth and gums caused by dentures or orthodontic appliances or injury to mouth and gums.

  • DOSAGE & ADMINISTRATION

    Adults and children12 years and over:

    • remove cap, break metal seal with cap point
    • apply directly to the gums or to the denture surface that comes in contact with the affected area of the gums
    • if you are using the dentures, wait a few minutes then reinsert dentures and you may use your regular denture adhesive with this product
    • 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 this product

    children under 12 years: consult a dentist or doctor

  • WARNINGS

    Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried to the blood. This can occur even if you have used this product before. Stop use and seek immedicate medical attention if you or a child in your care develops:

    • pale, gray or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    Alllergy alert: Do not use if you have a history of allergy to local anetsthetics such as procaine, butacaine, benzocaine, or other "caine: anesthetics. Localized allergic reactions may occur after prolonged or repeated use.

    Do not use

    • for more than 7 consecutive days unless directed by a dentist of a doctor
    • for teething
    • in children under 2 years of age

    When using this product

    • avoid contact with eyes
    • do not exceed recommended dosage

    Stop use and ssk a doctor or dentist if

    • sore mouth symptoms do not improve in 7 days
    • swelling, rash or fever develops
    • irritation, pain or redness persists or worsens

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • INACTIVE INGREDIENT

    cellulose gum, D&C red no.30 lake, eugneol, FD&C blue no. 1 lake, oxyquinoline sulfate, petrolatum

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    BENZODENT 
    benzocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71687-1053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    EUGENOL (UNII: 3T8H1794QW)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71687-1053-11 in 1 CARTON12/08/2017
    17 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71687-1053-21 in 1 CARTON12/08/2017
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/08/2017
    Labeler - Focus Consumer Healthcare, LLC (080743737)