Label: FLUORIDEX- stannous fluoride rinse liquid
- NDC Code(s): 59883-004-01
- 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)
- Active ingredient
- Purpose
- Use
- Warnings
- WARNINGS
-
Directions
Adults and children 6 years of age and older:
- Do not use before mixing with water
- Use once a day after brushing your teeth with a toothpaste
- Separate provided graduated cup from the mixing cap
- Fill graduated cup to 1/8oz. fill line with Fluoridex Daily Renewal Oral Rinse Concentrate
- Add warm water to 1 oz. fill line
- Place the mixing cap onto the filled cap until it snaps closed
- Shake thoroughly then remove mixing cap
- Use immediately after preparing the rinse
- Vigorously swish with half of the prepared solution between your teeth for 1 minute and then spit out
- Do not swallow the rinse
- Repeat the procedure with the remaining half of the prepared solution
- Do not eat or drink for 30 minutes after rinising
- Instruct children under 12 years of age 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
-
Other Information
- This product may produce surface staining of the teeth
- Adequatetoothbrushing may prevent these stains which are harmful or permanent and may be removed by your dentist
- Store at controlled room temperature 15º - 30ºC (59º - 86º F)
- See package insert for additional information
- For your protection, do not use if tamper seal on box is broken or missing
- Inactive Ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FLUORIDEX
stannous fluoride rinse liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59883-004 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) HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59883-004-01 1 in 1 BOX 01/11/2016 1 310 g in 1 BOTTLE, PLASTIC; 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 01/11/2016 Labeler - DEN-MAT HOLDINGS, LLC (809857704)
