DARBY APF STRAWBERRY

DARBY APF STRAWBERRY is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Darby Dental Supply, LLC taken by dental and marketed as a human prescription drug product. Identifiers on file: NDC 66467-8003, label effective 20230112. It is one of 118 FDA drug label records sharing the active ingredient SODIUM FLUORIDE. 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 SODIUM FLUORIDE are most often described in connection with: dental decay, fluoride treatment, help prevent, home unsupervised, usage stable, professional office, caries preventive, helps protect. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Directions For Use l. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment.

Warnings KEEP OUT OF REACH OF CHILDREN. For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104° F (40°C). Contents under pressure. Do not puncture or incinerate. Do not use if seal is broken.

FDA lists 118 drug label records with SODIUM FLUORIDE 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 DARBY APF STRAWBERRY used for?
The FDA label on file for this product does not include a full indications section. Other FDA labels sharing the active ingredient SODIUM FLUORIDE describe it in connection with: dental decay, fluoride treatment, help prevent, home unsupervised, usage stable, professional office, caries preventive, helps protect. Check the specific product label or ask a prescriber before use.

Who makes DARBY APF STRAWBERRY?
Darby Dental Supply, LLC is the labeler of record for DARBY APF STRAWBERRY. 118 FDA label records share the active ingredient SODIUM FLUORIDE, 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 DARBY APF STRAWBERRY come in?
administered by dental. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is DARBY APF STRAWBERRY prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing SODIUM FLUORIDE?
Yes. 118 FDA drug label records list SODIUM FLUORIDE 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 DARBY APF STRAWBERRY 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.