Label: PRO-DEN RX- stannous fluoride rinse
- NDC Code(s): 59883-720-08
- Packager: Den-mat Holdings, Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
-
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
- Inactive ingredients
- Principal Display Panel - Carton Label
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
PRO-DEN RX
stannous fluoride rinseProduct 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 1.53 mg 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 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 10/31/2008 Labeler - Den-mat Holdings, Llc (809857704)
