TopCare Calagesic
TopCare Calagesic is an FDA drug label for the active ingredient CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION manufactured by TOPCO ASSOCIATES LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231218.
- Generic name
- CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION
- Manufacturer
- TOPCO ASSOCIATES LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 36800-268
- Application
- M016
- Label effective
- 20231218
About this product
TopCare Calagesic is an FDA-registered drug product whose active ingredient is CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION. It is labelled by TOPCO ASSOCIATES LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 36800-268, application M016, label effective 20231218. 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.
What it is used for
Across FDA labelling, products containing CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION are most often described in connection with: temporarily relieves, itching poison, ivy oak, skin irritations. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations.
Dosage & Administration
Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort. Children under 2 yrs. of age. Consult a doctor before use.
Warnings
For external use only. Use only as directed. When using this product. Avoid contact with eyes and moucous membranes.
Frequently asked questions
What is TopCare Calagesic used for?
Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations.
Who makes TopCare Calagesic?
TOPCO ASSOCIATES LLC is the labeler of record for TopCare Calagesic.
What form does TopCare Calagesic 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 TopCare Calagesic 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 TopCare Calagesic 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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.