Fluoridex - 0.63% Stannous Fluoride Rinse

Fluoridex - 0.63% Stannous Fluoride Rinse
SPL v3
SPL
SPL Set ID 5e81f073-c0ca-aa38-e053-2a91aa0ab37b
Route
ORAL
Published
Effective Date 2018-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.53 mg)
Inactive Ingredients
Glycerin Hydrogenated Starch Hydrolysate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-01-11

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

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