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| Product NDC Code | 71687-1053 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Benzodent |
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| Type | Brand | ||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 723562, 1112942 |
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| Application Number | M017 | ||||||
| Labeler Name | Focus Consumer Healthcare, LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Benzocaine 20%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Adults and children 12 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
A list of inactive, non-medicinal ingredients in a drug product.cellulose gum, D&C red no.30 lake, eugneol, FD&C blue no. 1 lake, oxyquinoline sulfate, petrolatum
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.Benzodent Benzocaine FD&C BLUE NO. 1 D&C RED NO. 30 EUGENOL ALUMINUM OXIDE OXYQUINOLINE SULFATE PETROLATUM BENZOCAINE BENZOCAINE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.image image
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes do not exceed recommended dosage
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API