BINACA FLUORIDE ANTICAVITY MOUTHWASH- sodium fluoride liquid
Dr. Fresh, 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.

----------

Binaca Fluoride Anticavity Mouthwash

Active ingredient
Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose: .Anticavity Rinse

Uses

- Aids in the prevention of dental cavities

Keep out of reach of children under 6 years of age.

Warnings

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center 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 untill 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, Glycerine, PEG 40 hydrogenated castor oil, Xylitol, Poloxamer 407, Sorbitol, Peppermint Flavor, Sodium enzoate, Sodium saccharin, Cetylpyridinium chloride, Citric acid, Zinc gluconate, Acesulfame potassium, Calcium lactate, FDandCBlue#1

Question? Comments?

1-866-373-7374

comments@drfresh.com

www.drfresh.com

www.binaca.com

BINACA FLUORIDE ANTICAVITY MOUTHWASH
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64893-500
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SORBITOL (UNII: 506T60A25R)
PEPPERMINT (UNII: V95R5KMY2B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CALCIUM LACTATE (UNII: 2URQ2N32W3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64893-500-00	473 mL in 1 TUBE; Type 0: Not a Combination Product	09/02/2010	11/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/02/2010	11/30/2021

Labeler - Dr. Fresh, LLC (117376803)

Revised: 9/2021

Document Id: 7fff3c11-b0a8-4e66-8b31-0231b4be1b66

Set id: 23e05986-74a5-48b7-a654-6adc59b0bcda

Version: 7

Effective Time: 20210927

Dr. Fresh, LLC