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Benzodent by Focus Consumer Healthcare, LLC

Medically reviewed on December 8, 2017

Dosage form: cream
Ingredients: BENZOCAINE 0.2g in 1g
Labeler: Focus Consumer Healthcare, LLC
NDC Code: 71687-1053

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.

Benzodent

Pain reliever

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.

Benzocaine 20%

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

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

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

BENZODENT 
benzocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71687-1053
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE0.2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
D&C RED NO. 30 
EUGENOL 
OXYQUINOLINE SULFATE 
PETROLATUM 
ALUMINUM OXIDE 
Packaging
#Item CodePackage Description
1NDC:71687-1053-11 TUBE in 1 CARTON
17 g in 1 TUBE
2NDC:71687-1053-21 TUBE in 1 CARTON
228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/08/2017
Labeler - Focus Consumer Healthcare, LLC (080743737)
Establishment
NameAddressID/FEIOperations
Chattem Plant 1003336013manufacture(71687-1053)

 
Focus Consumer Healthcare, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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