Pro-den Rx Rinse
FDA Label NDC 59883-720

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Den-mat Holdings, Llc for the product Pro-den Rx (NDC 59883-720). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, otc - when using, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.