Label: BENZODENT- benzocaine cream 

  • NDC Code(s): 41167-0053-2, 41167-0053-4
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/11

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Benzocaine 20%

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  • Purpose

    Pain reliever

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  • Uses

    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

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  • Warnings

    Allergy alert: Do not use if you have a history of allergy to local anesthetics 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 or a doctor

    When using this product

    • avoid contact with eyes
    • do not exceed the recommended dosage

    Stop use and ask 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.

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

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  • Directions

    adults and children 2 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 with 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 2 years: consult a dentist or doctor

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  • Inactive ingredients

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

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  • PRINCIPAL DISPLAY PANEL

    Benzocaine 20%
    Benzodent®
    NET WT 0.25 OZ (7g)
    Dental Pain Relieving Cream

    PRINCIPAL DISPLAY PANEL
Benzodent®
NET WT 0.25 OZ (7g)

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  • INGREDIENTS AND APPEARANCE
    BENZODENT 
    benzocaine cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41167-0053
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 0.2 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE SODIUM  
    EUGENOL  
    OXYQUINOLINE SULFATE  
    PETROLATUM  
    D&C RED NO. 30  
    FD&C BLUE NO. 1  
    ALUMINUM OXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0053-2 1 in 1 CARTON
    1 7 g in 1 TUBE
    2 NDC:41167-0053-4 1 in 1 CARTON
    2 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 05/12/1994
    Labeler - Chattem, Inc. (003336013)
    Establishment
    Name Address ID/FEI Business Operations
    Chattem Plant 1 003336013 MANUFACTURE, PACK
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