Anticavity Fluoride Rinse: Package Insert and Label Information

ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
Value Merchandiser, CO

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.

Directiions

  • 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 ingredients

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

Questions?

Call 1-888-593-0593

Adverse Reactions to Anticavity Fluoride Rinse

This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Floride Mouthwash.

Call 1-844-292-1112 for more information.

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO

5000 KANSAS AVE

KANSAS CITY, KA 66106

principal display panel

Best Choice

Sealed With Printed Necband For Your Protection

COMPARE TO ACT (ANTICAVITY FLUORIDE MOUTHWASH)*

MINT

ANTICAVITY

Fluoride

Rinse

Helps Prevents Cavities

IMPORTANT: read directions for proper use.

18 FL OZ (532 mL)

image description
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ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-170
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 ANHYDROUS
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:63941-170-44 532 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 08/25/2021
Labeler — Value Merchandiser, CO (868703513)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (63941-170)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (63941-170)

Revised: 08/2021 Value Merchandiser, CO

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