BINACA FLUORIDE ANTICAVITY MOUTHWASH- sodium fluoride liquid

Binaca Fluoride Anticavity Mouthwash by

Drug Labeling and Warnings

Binaca Fluoride Anticavity Mouthwash by is a Otc medication manufactured, distributed, or labeled by Dr. Fresh LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose: .Anticavity Rinse

Uses

 - Aids in the prevention of dental cavities

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

Warnings

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

Other information Store at room temperature

INACTIVE INGREDIENT

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

QUESTIONS

Question? Comments?

1-866-373-7374

comments@drfresh.com

www.drfresh.com

www.binaca.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BINACA FLUORIDE ANTICAVITY MOUTHWASH 
sodium fluoride liquid

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Dr. Fresh LLC (117376803)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Fresh LLC		117376803	manufacture(64893-500)