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 Midwood Brands, 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.

Active Ingredient



Sodium fluoride 0.0221% (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 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
  • 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, phosphori acid, sucralose, menthol, disosium phosphate, red 40, blue 1


Disclaimer



This product is not manufacturd or distributed by Johnson + Johnson Healthcare Products,  owner of the registered trademark Listerine*

DISTRIBUTED BY:
FAMILY DOLLAR SERVICES, INC
10401 MONROE RD
MATTHEWS, NC 28105


Principal Display Panel



SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

FAMILY WELLNESS

COMPARE TO THE ACTIVE INGREDIENT OF LISTERINE TOTAL CARE ANTICAVITY MOUTHWASH

Anticavity Fluoride Mouthwash

Sodium Fluoride and Acidulated Phosphate Topical Solution

Helps Prevent Cavities

Strengthen Teeth and Kill Germs That Cause Bad Breath

Cleans Entire Mouth and Freshens Breath

Restores Enamel

EUCALYPTUS MINT

IMPORTANT: READ DIRECTIONS FOR PROPER USE

1 L (33.8 FL OZ)

163.004/163AE


* Please review the disclaimer below.