Maximum Strength Betadine Clear
Maximum Strength Betadine Clear is an FDA drug label for the active ingredient BENZALKONIUM CL AND PRAMOXINE HCL manufactured by Atlantis Consumer Healthcare, Inc. 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 20260831.
- Generic name
- BENZALKONIUM CL AND PRAMOXINE HCL
- Manufacturer
- Atlantis Consumer Healthcare, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 67618-183
- Application
- M003
- Label effective
- 20260831
About this product
Maximum Strength Betadine Clear is an FDA-registered drug product whose active ingredient is BENZALKONIUM CL AND PRAMOXINE HCL. It is labelled by Atlantis Consumer Healthcare, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 67618-183, application M003, label effective 20260831. 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 BENZALKONIUM CL AND PRAMOXINE HCL are most often described in connection with: first aid, help prevent, relieve pain, discomfort minor, cuts scrapes. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses First aid to help prevent infection and relieve pain or discomfort in minor • cuts • scrapes • burns
Dosage & Administration
Directions • adults and children 2 years of age and older: • clean the affected area • spray a small amount of this product on the area 1 to 3 times daily • may be covered with sterile bandage • if bandaged, let dry first • children under 2 years of age: • consult a doctor
Warnings
Warnings For external use only
Frequently asked questions
What is Maximum Strength Betadine Clear used for?
Uses First aid to help prevent infection and relieve pain or discomfort in minor • cuts • scrapes • burns
Who makes Maximum Strength Betadine Clear?
Atlantis Consumer Healthcare, Inc. is the labeler of record for Maximum Strength Betadine Clear.
What form does Maximum Strength Betadine Clear 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 Maximum Strength Betadine Clear 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 Maximum Strength Betadine Clear 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.