DOLODENT MAXIMUM STRENGTH- benzocaine liquid

Dolodent by

Drug Labeling and Warnings

Dolodent by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredient and Purpose

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Active ingredient Purpose

Benzocaine 20%..............................Oral pain reliever

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

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.

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

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

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.

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 a should be supervised in the use of the product
• children under 2 years of age: do not use

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

Dist. by/ por:

Dist. by/ por:

PHARMADEL LLC

New Castle, DE 19720

+1-866-359-3478

www.pharmadel.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

DOLODENT  MAXIMUM STRENGTH
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CLOVE OIL (UNII: 578389D6D0)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
SODIUM METHYLPARABEN (UNII: CR6K9C2NHK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-505-01	1 in 1 CARTON	05/14/2025
1		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	05/14/2025

Labeler - Pharmadel LLC (030129680)