Pro-Den Rx STANNOUS FLUORIDE DEN-MAT HOLDINGS, LLC FDA Approved Uses Aids in the prevention of dental caries (cavities). Control of perio infection Relief of dentin sensitivity
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Substance Stannous Fluoride
Route
ORAL
Applications
M021
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient Stannous Fluoride 0.63% w/w (0.19% w/v fluoride ion)
Inactive Ingredients
Inactive ingredients flavor glycerin methylparaben propylparaben sodium saccharin
Strengths
0.63 % 0.19 %
Treats Conditions
Uses Aids In The Prevention Of Dental Caries Cavities Control Of Perio Infection Relief Of Dentin Sensitivity

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
3FTR44B32Q
Packaging

Principal Display Panel - Carton Label NDC 59883-720-08 pro-denRx ® dye free rinse 0.63 % stannous fluoride cool mint flavor IMPORTANT: Read directions for proper use. 10 fl. oz. (283.5 g) Figure; Principal Display Panel NDC 59883-720-08 pro-denRx ® dye free rinse 0.63 % stannous fluoride mint flavor IMPORTANT: Read directions for proper use. 10 fl. oz. (283.5 g) Figure

Package Descriptions
  • Principal Display Panel - Carton Label NDC 59883-720-08 pro-denRx ® dye free rinse 0.63 % stannous fluoride cool mint flavor IMPORTANT: Read directions for proper use. 10 fl. oz. (283.5 g) Figure
  • Principal Display Panel NDC 59883-720-08 pro-denRx ® dye free rinse 0.63 % stannous fluoride mint flavor IMPORTANT: Read directions for proper use. 10 fl. oz. (283.5 g) Figure

Overview

Uses Aids in the prevention of dental caries (cavities). Control of perio infection Relief of dentin sensitivity

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

Warnings & Precautions
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.
Purpose

Purpose anticavity

When Using

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

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.


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