Prodenrx

Prodenrx
SPL v6
SPL
SPL Set ID 9036aa8a-59b1-41b0-b3cb-529d3303a1c0
Route
ORAL
Published
Effective Date 2015-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.53 mg)
Inactive Ingredients
Glycerin Methylparaben Propylparaben Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-10-31

Description

Drug Facts

Purpose

anticavity


Medication Information

Purpose

anticavity

Description

Drug Facts

Uses
  • Aids in the prevention of dental caries (cavities).
  • Control of perio infection
  • Relief of dentin sensitivity
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50567-7

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.

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
Active Ingredient

Stannous Fluoride 0.63% w/w

(0.19% w/v fluoride ion)

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

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)

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)


Structured Label Content

Uses
  • Aids in the prevention of dental caries (cavities).
  • Control of perio infection
  • Relief of dentin sensitivity
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50567-7 (50567-7)

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.

Purpose

anticavity

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
Active Ingredient

Stannous Fluoride 0.63% w/w

(0.19% w/v fluoride ion)

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

flavor, glycerin, methylparaben, propylparaben, sodium saccharin

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)

Principal Display Panel Carton Label (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)


Advanced Ingredient Data


Raw Label Data

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