Orajel Gum Pain 3X Medicated

Orajel Gum Pain 3X Medicated is an FDA-registered drug product whose active ingredient is BENZOCAINE, MENTHOL, ZINC CHLORIDE. It is labelled by Church & Dwight Co., Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 10237-792, application M022, label effective 20230120. 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, MENTHOL, ZINC CHLORIDE are most often described in connection with: temporary relief, pain due, minor 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 minor irritation or injury of the mouth and gums

Directions Adults and 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 between 2 and 12 years of age Ask a doctor before use. 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

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Orajel Gum Pain 3X Medicated used for?
Use for the temporary relief of pain due to minor irritation or injury of the mouth and gums

Who makes Orajel Gum Pain 3X Medicated?
Church & Dwight Co., Inc. is the labeler of record for Orajel Gum Pain 3X Medicated.

What form does Orajel Gum Pain 3X Medicated come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Orajel Gum Pain 3X Medicated 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.

Has Orajel Gum Pain 3X Medicated been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.