Drugplain

Topco 4x Medicated Toothache and Gum Gel .13 g/100g

Benzocaine · GEL · TopCare

No Recall History
Plain English

Topco 4x Medicated Toothache and Gum Gel is a gel containing benzocaine at .13 g/100g, taken oral. Manufactured by TopCare.

Key Facts

Brand Name
Topco 4x Medicated Toothache and Gum Gel
Generic Name
Benzocaine
NDC Code (Product)
36800-624
Manufacturer
TopCare
Strength
.13 g/100g
Dosage Form
GEL
Route
ORAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
11/18/2020

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

for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation

Dosage & Administration

cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. 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 2 years of age: do not use

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 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.

Frequently Asked Questions

What is Topco 4x Medicated Toothache and Gum Gel used for?

Topco 4x Medicated Toothache and Gum Gel contains Benzocaine. It is a gel taken oral. Consult your doctor for specific uses.

Is Topco 4x Medicated Toothache and Gum Gel a controlled substance?

Topco 4x Medicated Toothache and Gum Gel is not classified as a controlled substance by the DEA.

What is the generic name for Topco 4x Medicated Toothache and Gum Gel?

The generic name for Topco 4x Medicated Toothache and Gum Gel is Benzocaine. There are 12 other brand versions of Benzocaine.

What is the NDC code for Topco 4x Medicated Toothache and Gum Gel .13 g/100g?

The NDC (National Drug Code) for Topco 4x Medicated Toothache and Gum Gel .13 g/100g is 36800-624, listed by TopCare.