Drugplain

3X Medicated Toothache and Gum Gel 20 g/100g

Benzocaine · GEL · Rite Aid

No Recall History
Plain English

This toothache and gum gel contains benzocaine, a local anesthetic that temporarily numbs pain in the mouth and gums when applied directly to the affected area. It is available over-the-counter for short-term relief of minor oral discomfort.

Key Facts

Brand Name
3X Medicated Toothache and Gum Gel
Generic Name
Benzocaine
NDC Code (Product)
11822-0613
Manufacturer
Rite Aid
Strength
20 g/100g
Dosage Form
GEL
Route
ORAL
Marketing Status
Application #
M017
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
05/06/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

methaemoglobinaemia124 reports
drug ineffective89 reports
drug hypersensitivity61 reports
off label use59 reports
asthenia48 reports
nausea47 reports
dyspnoea38 reports
arthralgia36 reports
anxiety35 reports
amnesia33 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Methemoglobinemia warning: use of this product may cause methemoglobinema, a serious condition that must be treated promptly because it reduces the amount of oxygen in the blood. This can occur even if you have used this prouct 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 Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions Directions * cut open tip of tube on score mark * do not use if tip is cut prior to opening * adults adn children 2 years of age and older: apply to affected area 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 2 years of age: do not use

Warnings

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

Frequently Asked Questions

What is 3X Medicated Toothache and Gum Gel used for?

This toothache and gum gel contains benzocaine, a local anesthetic that temporarily numbs pain in the mouth and gums when applied directly to the affected area. It is available over-the-counter for short-term relief of minor oral discomfort.

Is 3X Medicated Toothache and Gum Gel a controlled substance?

3X Medicated Toothache and Gum Gel is not classified as a controlled substance by the DEA.

What is the generic name for 3X Medicated Toothache and Gum Gel?

The generic name for 3X Medicated Toothache and Gum Gel is Benzocaine. There are 12 other brand versions of Benzocaine.

What is the NDC code for 3X Medicated Toothache and Gum Gel 20 g/100g?

The NDC (National Drug Code) for 3X Medicated Toothache and Gum Gel 20 g/100g is 11822-0613, listed by Rite Aid.