PRO-DEN RX- stannous fluoride gel

Pro-Den Rx by

Drug Labeling and Warnings

Pro-Den Rx by is a Otc medication manufactured, distributed, or labeled by Den-mat Holdings, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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.

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)

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)

INGREDIENTS AND APPEARANCE

PRO-DEN RX 
stannous fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59883-720
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.8 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (MINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-720-08	1 in 1 CARTON	10/31/2008
1		283.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/31/2008

Labeler - Den-mat Holdings, Llc (809857704)