Caldesene Medicated Protecting

Caldesene Medicated Protecting is an FDA-registered drug product whose active ingredient is CORNSTARCH AND ZINC OXIDE. It is labelled by Insight Pharmaceuticals LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 63736-306, application M016, label effective 20260422. 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 CORNSTARCH AND ZINC OXIDE are most often described in connection with: helps treat, prevents diaper, rash temporarily, relieve minor, skin irritation. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses helps treat and prevents diaper rash temporarily protects and helps relieve minor skin irritation

Directions For diaper rash change wet or soiled diapers promptly cleanse the diaper area and allow to dry apply powder liberally, as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged apply powder close to the body away from child's face carefully shake the powder into the diaper or into the hand and apply to diaper area For minor skin irritations smooth on powder to protect irritated and chafed skin. Apply as needed.

Warnings For external use only . Do not use on broken skin. When using this product avoid contact with eyes keep away from face and mouth to avoid breathing it Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

4 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 Caldesene Medicated Protecting used for?
Uses helps treat and prevents diaper rash temporarily protects and helps relieve minor skin irritation

Who makes Caldesene Medicated Protecting?
Insight Pharmaceuticals LLC is the labeler of record for Caldesene Medicated Protecting.

What form does Caldesene Medicated Protecting 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 Caldesene Medicated Protecting 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 Caldesene Medicated Protecting been recalled?
4 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.