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 Heb. 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 0.05% (0.02% w/v fluoride ion)


Purpose



Anticavity Rinse


Use



aids in the prevention of dental cavities


Warning



for this product only


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.


Directions



  • 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 inside of cap); do not fill above 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do now 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 necessay 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



benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, green 3, menthol, methyl salicylate, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5.


Questions?



Call 1-888-593-0593


Ada Council Statement



"The ADA Council on Scientific Affairs Acceptance of HEB Anticavity Fluoride Rinse is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed."


Disclaimer



This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Mouthwash


Tep



SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION


Adverse Reactions



MADE WTH PRIDE AND CARE FOR H-E-B SAN ANTONIO, TX 78204


Principal Display Panel



Compare to ACT Anticavity

Fluoride Mouthwash

H-E-B

Mint

ANTICAVITY

FLUORIDE

MOUTH RINSE

ADA

Accepted

American

Dental

Association

  • Helps Prevent Cavities
  • Alcohol Free
  • Freshens Breath
  • IMPORTANT: read directions for proper use.

    18 FL OZ (1.1 PT) 532 mL



* Please review the disclaimer below.