Pro-Den Rx
Pro-Den Rx is an FDA drug label for the active ingredient STANNOUS FLUORIDE manufactured by Den-mat Holdings, Llc administered by ORAL. 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 20231120.
- Generic name
- STANNOUS FLUORIDE
- Manufacturer
- Den-mat Holdings, Llc
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 59883-720
- Application
- M021
- Label effective
- 20231120
Active ingredients
Indications & Usage
Uses Aids in the prevention of dental caries (cavities). Control of perio infection Relief of dentin sensitivity
Dosage & Administration
Directions Do not use before mixing with water Use immediately after preparing the rinse Adults and children 6 years of age and older: Use as directed by a dental professional Use once a day after brushing your teeth with a toothpaste or as directed by your dentist Remove cap and seal and replace with pump Rotate spout counter clockwise to extend Depress pump until medicine comes to the tip of the pump Put 1/8 oz. (approx. 2 pump strokes) of concentrated Pro-DenRx Rinse into the provided mixing vial Add water to 1 oz. line on mixing vial Tightly snap on the cap and shake well Vigorously swish between your teeth 1/2 of mixture for one minute and then spit out Repeat procedure with remaining mixture Rinse mixing vial with water after use Do not swallow the rinse Do not eat or drink for 30 minutes after rinsing Children 6 to 12 years of age: Instruct children in good rinsing habits (to minimize swallowing) Supervise children as necessary until capable of using without supervision Children under 6 years of age: Consult a dentist or doctor For home irrigation Prepare 1 oz. of Pro-DenRx Rinse as described above Pour into irrigator reservoir, add 4 oz. of water and mix thoroughly Use irrigator as directed Rinse irrigator with water after use
Contraindications
Not available.
Warnings
Warnings When using this product it may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. Keep out of reach of children. If more than used for rinsing s accidentally swallowed, get medical help or contact a Poison Control Center right away.
Adverse Reactions
Not available.