Anticavity Rinse
Care One 004.002/004AE Anticavity Fluoride Rinse, Bubble Gum
77c066cf-f064-45d3-9732-4433165ba9ef
HUMAN OTC DRUG LABEL
May 21, 2025
Retail Business Services, LLC
DUNS: 967989935
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (15)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
principal display panel
CAREONE ®
Compare to Act ®Kids Anticavity Fluride Rinse*
CHILDREN'S
ANTICAVITY
FLUORIDE RINSE
Strong Cavity
Protection
Alcohol-Free
BUBBLE GUM FLAVOR
Sealed with printed neckband for your protection
IMPORTANT: Read directions for proper use.
18 FL OZ (532 mL)
INDICATIONS & USAGE SECTION
Use
aids in the prevention of dental cavities
ADVERSE REACTIONS SECTION
ADVERSE REACTION
Distributed by Foodhold, U.S.A, LLC
Landover, MD 20785 • 1-877-846-9949
©2018 S&S Brands, Inc.
Quality Guaaranteed or your money back.
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Sodium Fluoride 0.05% (0.02% w/v fluoride ion)
OTC - PURPOSE SECTION
Purpose
Anticavity Rinse
WARNINGS SECTION
Warnings
for this product
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
DOSAGE & ADMINISTRATION SECTION
Directions
- adults and children 6 year 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 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 year of age: consult a dentist or doctor
STORAGE AND HANDLING SECTION
Other information
store at room temperature
INACTIVE INGREDIENT SECTION
Inactive ingredients
benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxomer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water
SPL UNCLASSIFIED SECTION
Disclaimer
*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ®Kids Anticavity Fluoride Rinse Bubblegum Blowout .