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 Rite Aid. 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.
Active Ingredient
Sodium fluoride 0.0221% (0.01% w/v fluoride ion)
Purpose
Anticavity
Use
aids in the prevention of dental cavities
Warnings
Warning
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and older:
- use twice daily after brushing your teeth with toothpaste
- vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and 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 12 years of age: consult a dentist or doctor
Other Information
- store at controlled room temperature 20⁰ -25⁰ C (68⁰ - 77⁰ F)
- cold weather may temporarily cloud this product
Inactive Ingredients
water, alcohol (21.6%), sorbitol, poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disosium phosphate, red 40, blue 1
Other
*This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash
DISTRIBUTED BY:
RITE AID
3O Hunter Lane, Camp Hill, PA 17011
DSP-TN-1500
DSP-MO-34
SDS-TN-15012
Principal Display Panel
RITE AID PHARMACY
Sealed With Printed Neckband For Your Protection
IMPORTANT: READ DIRECTIONS FOR PROPER USE
*Compare to the active ingredient in Listerine Total Care Anticavity Mouthwash
Anticavity Mouthwash
Sodium Fluoride and Acidulated Phosphate Topical Solution
fresh mint
helps prevent cavities
restores enamel
helps strengthen teeth
helps kill bad breath germs
leaves the mouth feeling clean
1 LITER ( 33.8 FL OZ)
* Please review the disclaimer below.