What is obtundia cream?

Composition

Chlorobutanol 1% w/w, phenol 1% w/w, propylene glycol 5.8% w/w.

Indications and Usage

* Temporary surface anesthesia of painful oral lesions.

* Anorectal discomfort.

Route of Administration

* Administer orally.

Dosage and Administration

To be used only under the supervision of a physician.

Adults and children 2 years of age and older:

* Do not swallow, hold drug against affected areas for at least 1 minute

* Apply no oftener than every 3 hours when needed.

Dosing in specific populations:

* Do not use in children less than 2 years of age.

Contraindications

* History of hypersensitivity to obtundia.

* Mouthwash for canker sores.

* Toothache in children.

* Teething in children.

* Topical anesthetic on genitalia.

* Local anesthesia for incision, and drainage of anorectal abscesses.

Warnings and Precautions

* Contains benzethonium chloride which can cause nasal septum ulcerations.

* Avoid prolonged use on large areas.

* Use on large denuded areas results in a higher rate of absorption in blood due to loss of protective membrane.

* For use in mouth and throat: Do not administer more than 2 hours before meals or bedtime in order to avoid aspiration of the product while asleep.

* For prolonged use, take frequent rests from medication to avoid potential for over-medication and adverse effects as follows: restlessness, tremors, lightheadedness, nausea, vomiting, cardiovascular or central nervous system depression.

Adverse Effects

* Dryness, burning, stinging sensation, numbness, swelling.

* Allergic reactions.

How to Store and Handle

* Store at temperature below 40°C

* Protect from light.