FDA Label for Oral Antivavity

View Indications, Usage & Precautions

Oral Antivavity Product Label

The following document was submitted to the FDA by the labeler of this product Topco. 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.

Claims



SEALED WITH PRINTED NECKBAND FOR YOUR PROTECION

TopCare

everyday

  • Helps strengthen enamel
  • Helps prevent cavities
  • Kills bad breath germs
  • Freshen Breath

Active Ingredient



Sodium fluoride 0.0219% (0.01% w/v fluoride ion)


Purpose



Anticavity


Use



aids in the prevention of dental cavities


Warnings



Warnings


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 bwtween 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 witout supervision
  • children under 6 years of age: consult a dentist or doctor

Inactive Ingredients



water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1


Questions?



Call 1-888-423-0139


Other



DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLATE, IL 60007

©TOPCO VIJA0122  QUESTIONS? 1-888-423-0139

This rinse may cause temporary staining to the surface of teeth. This is not harmful, add adequate brushing may prevent its occurence

This product is not manufactured or distributed by Procter & Gamble, distributof of Crest Pro-Health Advanced Anticavity Fluoride Mouthwash

This product is not intended to replace brushing or flossing


Principal Display Panel



COMPARE TO CREST PRO-HEALTH ADVANCED ANTICAVITY FLUORIDE MOUTHWASH

TopCare

everyday

ALOHOL FREE

Fluoride

Anticavity Mouthwash

REFRESHING MINT

  • Helps strengthen enamel
  • Helps prevent cavities
  • Cleans teeth**
  • Kills bad breath germs
  • Freshens breath
  • Helps keep mouth feeling clean
  • IMPORTANT: Read directions for proper use.

    33.8 FL OZ (1 QT 1.8 FL OZ) 1 L


* Please review the disclaimer below.