Drugplain

Pro-Den Rx 1.53 mg/g

Stannous Fluoride · RINSE · Den-mat Holdings, Llc

No Recall History
Plain English

Pro-Den Rx is a rinse containing stannous fluoride at 1.53 mg/g, taken oral. Manufactured by Den-mat Holdings, Llc.

Key Facts

Brand Name
Pro-Den Rx
Generic Name
Stannous Fluoride
NDC Code (Product)
59883-720
Manufacturer
Den-mat Holdings, Llc
Strength
1.53 mg/g
Dosage Form
RINSE
Route
ORAL
Marketing Status
Application #
M021
Marketing Start
10/31/2008

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 irri

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.

Frequently Asked Questions

What is Pro-Den Rx used for?

Pro-Den Rx contains Stannous Fluoride. It is a rinse taken oral. Consult your doctor for specific uses.

Is Pro-Den Rx a controlled substance?

Pro-Den Rx is not classified as a controlled substance by the DEA.

What is the generic name for Pro-Den Rx?

The generic name for Pro-Den Rx is Stannous Fluoride. There are 12 other brand versions of Stannous Fluoride.

What is the NDC code for Pro-Den Rx 1.53 mg/g?

The NDC (National Drug Code) for Pro-Den Rx 1.53 mg/g is 59883-720, listed by Den-mat Holdings, Llc.