Otc - Purpose
Pain reliever
Benzodent Cream
FDA Label NDC 71687-1053
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Focus Consumer Healthcare, Llc for the product Benzodent (NDC 71687-1053). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, indications & usage, otc - active ingredient, inactive ingredient, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - Active Ingredient
Benzocaine 20%
Inactive Ingredient
cellulose gum, D&C red no.30 lake, eugneol, FD&C blue no. 1 lake, oxyquinoline sulfate, petrolatum (245-003)
Warnings
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
- feel faint
- 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.
Otc - 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
* Please review the disclaimer below.
