Label: BENZODENT- benzocaine cream

  • NDC Code(s): 71687-1053-1, 71687-1053-2
  • Packager: Focus Consumer Healthcare, LLC
  • 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 June 9, 2020

If you are a consumer or patient 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.

  • 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

    • if you are allergic to aspirin or any other pain reliever/fever reducer

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if

    • you have liver disease
    • the stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic

    Ask a doctor or pharmacist before use

    if you are taking a prescription drug for gout, diabetes or arthritis

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • redness or swelling is present
    • new symptoms occur
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • ringing in the ears or loss of hearing occurs

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

  • 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

  • INACTIVE INGREDIENT

    cellulose gum, D&C red no.30 lake, eugneol, FD&C blue no. 1 lake, oxyquinoline sulfate, petrolatum (245-003)

  • 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)  
    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 not finalpart35612/08/2017
    Labeler - Focus Consumer Healthcare, LLC (080743737)