Anticavity Fluoride Rinse Mouthwash
FDA Label NDC 55319-163

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Stores, Inc for the product Anticavity Fluoride Rinse (NDC 55319-163). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Image Description (Mm1)

Image Description (Mm1)

* Please review the disclaimer below.