ORCA Complete Menthol Pain Reliever

ORCA Complete Menthol Pain Reliever is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by ORCA Products, LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 82939-000, application M022, label effective 20231208. It is one of 193 FDA drug label records sharing the active ingredient MENTHOL. 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 MENTHOL 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 12 years of age and older: Place 8-10 drops onto ORCA Foam or similar resorbable gelatin sponge or gauze strip in a sterile fashion and apply to areas of discomfort in oral region. Guaze strip requires removal. Orca Foam soaked sponge will resorb and does not require removal. Children under 12 years of age should be supervised in use of this product. Children under 12 years of age: Consult a dentist or doctor.

Warnings Do not use this product for more than 7 days unless directed by a dentist or doctor. When using this product do not exceed recommended dosage. Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

FDA lists 193 drug label records with MENTHOL 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 ORCA Complete Menthol Pain Reliever used for?
Use for the temporary relief of pain due to minor irritation or injury of the mouth and gums

Who makes ORCA Complete Menthol Pain Reliever?
ORCA Products, LLC is the labeler of record for ORCA Complete Menthol Pain Reliever. 193 FDA label records share the active ingredient MENTHOL, 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 ORCA Complete Menthol Pain Reliever 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 ORCA Complete Menthol Pain Reliever 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 MENTHOL?
Yes. 193 FDA drug label records list MENTHOL 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 ORCA Complete Menthol Pain Reliever 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.