Candee Caine Topical Anesthetic

Candee Caine Topical Anesthetic is an FDA-registered drug product whose active ingredient is BENZOCAINE. It is labelled by Top Quality Manufacturing, Inc. taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 69301-056, application M022, label effective 20260806. 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: oral mucosal, only directed, temporary relief, pain due, minor dental. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Apply only amount needed to the oral mucosa to prevent or relieve pain. 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 the 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 on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. Do not use for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age When using this product Avoid contact with eyes. If contact occurs, flush with water. Do not exceed recommended dosage . If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast feeding , ask a physician before use.

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 Candee Caine Topical Anesthetic used for?
For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Who makes Candee Caine Topical Anesthetic?
Top Quality Manufacturing, Inc. is the labeler of record for Candee Caine Topical Anesthetic. 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 Candee Caine Topical Anesthetic come in?
administered by dental. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Candee Caine Topical Anesthetic 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 Candee Caine Topical Anesthetic 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.