Active Ingredient
Sodium fluoride 0.05% (0.02% w/v fluoride ion)
Anticavity Fluoride Mouthwash
FDA Label NDC 55319-807
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 (family Wellness) for the product Anticavity Fluoride (NDC 55319-807). 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, uses, keep out of reach of children., directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity rinse
Uses
aids in the prevention of dental cavities
Keep Out Of Reach Of Children.
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Adults and children 6 years of age and older:
■ use once a day after brushing your teeth with a toothpaste
■ vigorously swish 10 milliliters 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
Other Information
■ store at room temperature
■ do not use if safety seal is broken or missing
Inactive Ingredients
water, sorbitol, propylene glycol, flavor, poloxamer 407, monosodium phosphate, benzyl alcohol, disodium phosphate, sodium benzoate, sodium saccharin, polysorbate 80, cetylpyridinium chloride, calcium disodium EDTA, D&C red no. 33
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse*
Children's
ANTICAVITY
FLUORIDE RINSE
6+ YEARS
Sodium Fluoride 0.05%
- Help prevent cavities
- Alcohol Free
IMPORTANT: Read directions for proper use.
BUBBLEGUM FLAVOR
TAMPER EVIDENT: DO NOT USE IF PRINTER SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Chattem Inc., distributor of ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
510 VOLVO PKWY, CHESAPEAKE, VA 23320
Package Label
FAMILY WELLNESS Children's Anticavity Fluoride Rinse Bubblegum Flavor
* Please review the disclaimer below.
