FDA Label for Alcohol-free Anticavity
View Indications, Usage & Precautions
Alcohol-free Anticavity Product Label
The following document was submitted to the FDA by the labeler of this product Retail Business 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 Ingredients
Sodium fluoride 0.02% (0.0 1% w/v fluoride ion)
Purpose
Anticavity
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, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 6 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
- 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
Inactive Ingredients
water, glycerin, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3
Claims
This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurence.
Dislcaimer
Ths product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Complete Anticavity Fluoride Rinse.
482.001/482AB
Adverse Reaction
DISTRIBUTED BY:
FODHOLD U.S.A., LLC
LANDOVER, MD 20785
1-877-846-9949
Principal Display Panel
Compare to the Active Ingredient in Crest Pro-Health Advanced Anticavity Fluoride Mouthwash
CAREONE
ALCOHOL FREE FLUORIDE
MOUTH
WASH
ANTICAVITY FLUORIDE RINSE
VIOLET MINT FLAVOR
Kills Bad Breath Germs
Helps Prevent Cavities
Helps Strengthen Enamel
Cleans Teeth
Freshens Breath
1 LITER
(3.8 FL OZ)
IMPORTANT: Read directions for proper use
* Please review the disclaimer below.