FDA Label for Anticavity Fluoride Rinse
View Indications, Usage & Precautions
Anticavity Fluoride Rinse Product Label
The following document was submitted to the FDA by the labeler of this product Amazon.com Services Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Tep
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Active Ingredient
Sodium fluoride 0.05
5 (0.02% w/v fluoride ion)
Purpose
Anticavity rinse
Use
aids in the prevention of dental cavities
Warning
for this product
Keep Out Of Reach Of Children
If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.
Directiions
- adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
- remove cap
- pour 10 milliliters (10 mL mark on the inside of cap); do not fill above the 10 mL mark
- vigorously swish 10 milliliters of rinse between your teeth for 1 minute then spit out
- do not swallow the rinse
- do not eat or drink for 30 minutes after rinsing
- 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
- store at room temperature
Inactive Ingredients
water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5
Adverse Reactions
DISTRIBUTED BY:
Amazon.com Services, Inc.
Seattle, WA 98109
1-877-485-0385
2018 Amazon.com, Inc. or its affiliates. All rights reserved. Solimo and all related logos are trademarks of Amazon.com Inc. or its affiliates.
213.002/213AE rev 2
Principal Display Panel
SOLIMO
Anticavity
Fluoride Rinse
Mint flavor
Alcohol free
IMPORTANT: READ DIRECTIONS FOR PROPER USE
18 FL OZ(532 mL)
* Please review the disclaimer below.