Anticavity Fluoride Rinse: Package Insert and Label Information

ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
Retail Business Services, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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 the inside of cap); do not fill above the 10 mL mark
• vigorously swish 10 milliliters of rinse between your teeth for 1 minute 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

Inactive ingredient

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

Disclaimer

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

DISTRIBUTED BY: FOODHOLD, U.S.A., LLC

Landover, MD 20785 1-877-846-9949

(c) 2018 S7S Brands, LLC

Quality guaranteed or your money back.

Principal Panel Display

CAREONE

Compare to Act Anticavity Fluoride Rinse*

ANTICAVITY

FLUORIDE RINSE

MINT FLAVOR

Sealed With Printed Neckband For Your Protection

IMPORTANT: Read directions for proper use

18 FL OZ (532 mL)

ANTICAVITY FLUORIDE RINSE sodium fluoride mouthwash

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-213 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.2 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER SORBITOL MENTHOL METHYL SALICYLATE CETYLPYRIDINIUM CHLORIDE SACCHARIN SODIUM POLOXAMER 407 POLYSORBATE 20 PROPYLENE GLYCOL SODIUM PHOSPHATE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS EDETATE CALCIUM DISODIUM MONOHYDRATE EDETATE DISODIUM ANHYDROUS SODIUM BENZOATE POTASSIUM SORBATE BENZYL ALCOHOL FD&C GREEN NO. 3 FD&C YELLOW NO. 5

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72476-213-44 532 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 05/24/2010

Labeler — Retail Business Services, LLC (967989935)

Registrant — Vi-Jon, LLC (790752542)

Establishment
Name	Address	ID/FEI	Operations
Vi-Jon, LLC		790752542	manufacture (72476-213)

Establishment
Name	Address	ID/FEI	Operations
Vi-Jon, LLC		088520668	manufacture (72476-213)

Revised: 05/2023 Retail Business Services, LLC