Benzodent

Benzodent
SPL v7
SPL
SPL Set ID 5fdcb871-d387-6352-e053-2991aa0a09da
Route
TOPICAL
Published
Effective Date 2025-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (0.2 g)
Inactive Ingredients
Fd&c Blue No. 1 D&c Red No. 30 Eugenol Aluminum Oxide Oxyquinoline Sulfate Petrolatum Carboxymethylcellulose Sodium, Unspecified Form

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-08

Description

Benzocaine 20%


Medication Information

Warnings and Precautions

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.

Indications and 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.

Dosage and Administration

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

Description

Benzocaine 20%

Section 51727-6

cellulose gum, D&C red no.30 lake, eugneol, FD&C blue no. 1 lake, oxyquinoline sulfate, petrolatum

Section 51945-4

Section 55105-1

Pain reliever

Section 55106-9

Benzocaine 20%

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
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 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

Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 51727-6 (51727-6)

cellulose gum, D&C red no.30 lake, eugneol, FD&C blue no. 1 lake, oxyquinoline sulfate, petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain reliever

Section 55106-9 (55106-9)

Benzocaine 20%

Do Not 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 (When using this product)
  • avoid contact with eyes

  • do not exceed recommended dosage
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Stop Use and Ssk A Doctor Or Dentist If (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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)