CalaSoothe

CalaSoothe is an FDA-registered drug product whose active ingredient is CALAMINE, MENTHOL, AND ZINC OXIDE. It is labelled by Dynarex Corporation taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 67777-241, application M015, label effective 20260624. 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 CALAMINE, MENTHOL, AND ZINC OXIDE are most often described in connection with: weeping poison, ivy oak, sumac helps, discomfort associated, anorectal disorders, temporary relief, provide cooling. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses • Dries the oozing and weeping of poison: • ivy •oak • sumac • Helps relieve the itching and discomfort associated with anorectal disorders • For the temporary relief of irritation and burning • May provide a cooling sensation

Directions • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times daily or after each bowel movement. • Children under 12 years of age: Consult a doctor

Warnings For external use only Stop use and ask a doctor if • condition worsens or does not improve within 7 days, concult a doctor • bleeding occurs • redness, irritation, swelling, or pain develops or increases When using this product • Do not exceed the recommended daily dosage unless directed by a doctor • Certain people can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symtoms develop or increase, discontinue use and consult a doctor. • Do not put this product into the rectum by using fingers or any mechanical device or applicator If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

1 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 CalaSoothe used for?
Uses • Dries the oozing and weeping of poison: • ivy •oak • sumac • Helps relieve the itching and discomfort associated with anorectal disorders • For the temporary relief of irritation and burning • May provide a cooling sensation

Who makes CalaSoothe?
Dynarex Corporation is the labeler of record for CalaSoothe.

What form does CalaSoothe 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 CalaSoothe 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 CalaSoothe been recalled?
1 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.