4x Medicated Toothache and Gum Cream

4x Medicated Toothache and Gum Cream is an FDA-registered drug product whose active ingredient is BENZOCAINE. It is labelled by CVS taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69842-631, application M022, label effective 20260420. It is one of 70 FDA drug label records sharing the active ingredient BENZOCAINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BENZOCAINE are most often described in connection with: temporary relief, pain due, toothaches help, protect against, infection minor, oral irritation. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Directions 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 teh use of this product * children under 2 years of age: do not use

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 or 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.

FDA lists 70 drug label records with BENZOCAINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is 4x Medicated Toothache and Gum Cream used for?
Use for the temporary relief of pain due to toothaches * to help protect against infection or minor oral irritation

Who makes 4x Medicated Toothache and Gum Cream?
CVS is the labeler of record for 4x Medicated Toothache and Gum Cream. 70 FDA label records share the active ingredient BENZOCAINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does 4x Medicated Toothache and Gum Cream come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is 4x Medicated Toothache and Gum Cream prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BENZOCAINE?
Yes. 70 FDA drug label records list BENZOCAINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has 4x Medicated Toothache and Gum Cream been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.