Drugplain

4X Medicated Severe Toothache and Gum Cream .13 g/100g

Benzocaine · CREAM · Rite Aid

No Recall History
Plain English

This is a topical cream containing benzocaine, a local anesthetic used to temporarily relieve severe toothache and gum pain when applied directly to the affected area in your mouth. It works by numbing the area to reduce discomfort from dental pain.

Key Facts

Brand Name
4X Medicated Severe Toothache and Gum Cream
Generic Name
Benzocaine
NDC Code (Product)
11822-0614
Manufacturer
Rite Aid
Strength
.13 g/100g
Dosage Form
CREAM
Route
ORAL
Marketing Status
Application #
M022
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

Warnings Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces teh 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 * symtoms 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 * dults and children 2 years of age and older; apply a small amount of product to the cavity and around teh 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

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 4X Medicated Severe Toothache and Gum Cream used for?

This is a topical cream containing benzocaine, a local anesthetic used to temporarily relieve severe toothache and gum pain when applied directly to the affected area in your mouth. It works by numbing the area to reduce discomfort from dental pain.

Is 4X Medicated Severe Toothache and Gum Cream a controlled substance?

4X Medicated Severe Toothache and Gum Cream is not classified as a controlled substance by the DEA.

What is the generic name for 4X Medicated Severe Toothache and Gum Cream?

The generic name for 4X Medicated Severe Toothache and Gum Cream is Benzocaine. There are 12 other brand versions of Benzocaine.

What is the NDC code for 4X Medicated Severe Toothache and Gum Cream .13 g/100g?

The NDC (National Drug Code) for 4X Medicated Severe Toothache and Gum Cream .13 g/100g is 11822-0614, listed by Rite Aid.

Product NDC

11822-0614

Package NDC

11822-0614-9

Other Benzocaine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)