Dolodent (wp)(da)

Dolodent (wp)(da)
SPL v3
SPL
SPL Set ID 351ecc2b-cc1a-2bbf-e063-6394a90a5c14
Route
TOPICAL
Published
Effective Date 2025-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Alcohol Clove Oil Glycerin Polyethylene Glycol, Unspecified Sodium Saccharin Sodium Methylparaben Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-05-14 Until 2027-06-01

Description

.

Purpose

.


Medication Information

Purpose

.

Description

.

Uses

For the temporary relief of

  • canker sores
  • minor injury of the mouth and gums
  • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Section 55105-1
Active ingredient Purpose
Benzocaine 20%...................... Oral pain reliever

Warnings

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 in blood. This can occur even if you have used this product before. Stop use and seek immediate 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

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics.

Flammable. Keep away from fire or flame. Avoid smoking during application.

Directions
  • adults and children 2 years of age and older:
  • apply product to a cotton swab or finger to the affected area. Allow to remain in place at least 1 minute and then spit out. 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 the product
  • children under 2 years of age: do not use
Do Not Use
  • more than directed
  • for more than 7 days unless directed by a dentist or doctor
  • for teething
  • in children under 2 years of age
Dist. By/ Por:

Dist. by/ por:

PHARMADEL LLC

New Castle, DE 19720

+1-866-359-3478

www.pharmadel.com

Other Information
  • do not use if clear seal over cap is torn, broken, or missing
  • store between 68-77°F (20-25°C)
Inactive Ingredients

alcohol, clove oil, glycerin, polyethylene glycol, propylene glycol, sodium saccharin, sodium methylparaben

Questions Or Comments?

+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Principal Display Panel

Active Ingredient and Purpose

.

Keep Out of Reach of Children.

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

Stop Use and Ask Your Doctor Or Dentist If
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

Structured Label Content

Uses

For the temporary relief of

  • canker sores
  • minor injury of the mouth and gums
  • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Section 55105-1 (55105-1)
Active ingredient Purpose
Benzocaine 20%...................... Oral pain reliever

Warnings

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 in blood. This can occur even if you have used this product before. Stop use and seek immediate 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

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics.

Flammable. Keep away from fire or flame. Avoid smoking during application.

Directions
  • adults and children 2 years of age and older:
  • apply product to a cotton swab or finger to the affected area. Allow to remain in place at least 1 minute and then spit out. 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 the product
  • children under 2 years of age: do not use
Do Not Use (Do not use)
  • more than directed
  • for more than 7 days unless directed by a dentist or doctor
  • for teething
  • in children under 2 years of age
Dist. By/ Por: (Dist. by/ por:)

Dist. by/ por:

PHARMADEL LLC

New Castle, DE 19720

+1-866-359-3478

www.pharmadel.com

Other Information (Other information)
  • do not use if clear seal over cap is torn, broken, or missing
  • store between 68-77°F (20-25°C)
Inactive Ingredients (Inactive ingredients)

alcohol, clove oil, glycerin, polyethylene glycol, propylene glycol, sodium saccharin, sodium methylparaben

Questions Or Comments? (Questions or comments?)

+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Principal Display Panel

Active Ingredient and Purpose (Active ingredient and Purpose)

.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Ask Your Doctor Or Dentist If (Stop use and ask your doctor or dentist if)
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

Advanced Ingredient Data


Raw Label Data

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