FDA Label for Anticavity
View Indications, Usage & Precautions
Anticavity Product Label
The following document was submitted to the FDA by the labeler of this product Onpoint, Inc. 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.
Otc - Active Ingredient
Active ingredientsSodium fluoride 0.221%(0.021% w/v fluoride ion)
Otc - Purpose
PurposeAnticavity
Indications & Usage
Use aids in the prevention of dental cavities
Warnings
Warnings
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.
Dosage & Administration
DirectionsAdults and children 12 years of age and older:•use twice daily after brushing your teeth with a 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•supervise children as necessary until capable of using without supervision•children under 12 years of age: consult a dents or doctor
Storage And Handling
Other information•store at controlled room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰F)•cold weather may temporarily cloud this product
Inactive Ingredient
Inactive ingredients water, sorbitol solution; alcohol (21.6%), flavors, poloxamer 407, sodium lauryl sulfate, phosphoric acid, sucralose and /or sodium saccharin,diabasic sodium phosphate, D+C red no.33, FD+C blue no.1, FD+C yellow no.6
Other
This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine Total CareDSP-TN-15000DSP-MO-34SDS-TN-15012
Adverse Reactions
DISTRIBUTED BYONPOINT, INC2 PARAGON DRIVEMONTVALE, NJ 07645
Package Label.Principal Display Panel
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTIONLive BetterAnticavityMouthwashSodium Fluoride and AcidulatedPhosphate Topical SolutionICE MINTCompare to Active Ingredients in Listerine Total Care•HELPS PREVENT CAVITIES•RESTORES ENAMEL•HELPS STRENGTHEN TEETH•HELPS KILL GERMS THAT CAUSE BAD BREATH•FRESHENS BREATHIMPORTANT: READ DIRECTIONS FOR PROPER USE.1L (33.8 FL OZ)
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