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  5. Label Information: Pro-den Rx

FDA Label for Pro-den Rx

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. OTC - WHEN USING
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. PRINCIPAL DISPLAY PANEL - CARTON LABEL
    11. PRINCIPAL DISPLAY PANEL - TUBE LABEL

Pro-den Rx Product Label

The following document was submitted to the FDA by the labeler of this product Den-mat Holdings, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Active Ingredient



Stannous Fluoride 0.63% w/w

(0.19% w/v fluoride ion)


Purpose



anticavity


Uses



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

Otc - 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.


Otc - 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.


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

Other Information



For your protection, do not use if seal under the cap is broken or missing.


Inactive Ingredients



flavor, glycerin, methylparaben, propylparaben, sodium saccharin


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 - pro10 0000 01

Figure - pro10 0000 01


Principal Display Panel - Tube Label



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 - pro10 0000 02

Figure - pro10 0000 02


* Please review the disclaimer below.