Active Ingredient
Stannous Fluoride 0.63% Rinse Concentrate
Fluoridex Liquid
FDA Label NDC 59883-004
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 Fluoridex (NDC 59883-004). 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 active ingredient, purpose, use, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use
Aids in the prevention of dental cavities
Warnings
Do not swallow the rinse
Keep out of reach of children under 6 years of age.
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away
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 toothpaste
- Separate provided graduated cup from the mixing cap
- Lift spout and 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
- Consult a dentist or doctor
Children under 6 years of age
Other Information
- For Professional Office Use Only
- This product is not intended for home or unsupervised consumer use
- This product may produce surface stains which are not harmful or permanent and may be removed by your dentist
- Store at controlled room temperature 15° - 30°C (59° - 86° F)
- For your protection, do not use if tamper seal on box is broken or missing
Inactive Ingredients
Glycerin, Hydrogenated Starch Hydrolysate, Flavor
Questions Or Comments?
Call: 1-800-752-2564
Principal Display Panel
NDC 59883-004-01
FLUORIDEX
DAILY
RENEWAL
Prescription-Strength
Dental Decay Prevention
Oral Rinse Concentrate
CLEAN MINT
8.4 fl. oz. (248 ml) 0.63% Stannous Fluoride Rx Only
* Please review the disclaimer below.
