Fluoridex - 0.63% Stannous Fluoride Rinse
5e81f073-c0ca-aa38-e053-2a91aa0ab37b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Stannous Fluoride 0.63% Rinse Concentrate
Purpose
Anticavity
Medication Information
Warnings and Precautions
Do not swallow the rinse
Purpose
Anticavity
Description
Stannous Fluoride 0.63% Rinse Concentrate
Use
- Aids in the prevention of dental cavities
Section 51945-4
NDC 59883-004-01
FLUORIDEX
DAILY
RENEWAL
Prescription-Strength
Dental Decay Prevention
Oral Rinse Concentrate
CLEAN MINT
0.63% Stannous Fluoride
8.4 fl. oz. (248 ml) Rx Only
Warnings
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 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
Active Ingredient
Stannous Fluoride 0.63% Rinse Concentrate
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
Glycerin, Hydrogenated Starch Hydrolysate, Flavor
Questions Or Comments?
Call: 1-800-752-2564
Structured Label Content
Use
- Aids in the prevention of dental cavities
Warnings and Precautions (34071-1)
Do not swallow the rinse
Section 51945-4 (51945-4)
NDC 59883-004-01
FLUORIDEX
DAILY
RENEWAL
Prescription-Strength
Dental Decay Prevention
Oral Rinse Concentrate
CLEAN MINT
0.63% Stannous Fluoride
8.4 fl. oz. (248 ml) Rx Only
Purpose
Anticavity
Warnings
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 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
Active Ingredient (Active ingredient)
Stannous Fluoride 0.63% Rinse Concentrate
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
Glycerin, Hydrogenated Starch Hydrolysate, Flavor
Questions Or Comments? (Questions or comments?)
Call: 1-800-752-2564
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:31.296620 · Updated: 2026-03-14T23:02:08.105317