BINACA ANTICAVITY FLOURIDE PEPPERMINT- sodium monofluorophosphate paste, dentifrice

Binaca Anticavity Flouride Peppermint by

Drug Labeling and Warnings

Binaca Anticavity Flouride Peppermint by is a Otc medication manufactured, distributed, or labeled by Dr. Fresh, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Sodium Monofluorophosphate (0.76%)

Purpose

Anitcavity

Uses

Helps protect against cavities.

Warnings

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

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

Inactive Ingredients

Calcium Carbonate, Carboxymethyl Cellulose, Flavor, Glycerin, Hydrated Silica, Sodium Benzoate, Sodium Lauryl Sulphate, Sodium Saccharin, Sorbitol, Tetrasodium Pyrophosphate, Water.

Directions

• Adults and children 2 years of age and older:  brush teeth thoroughly after meals or at least twice a day as directed by a dentist or physician.  
• Do not swallow.  
• To minimize swallowing use a pea-sized amount in children under 6.  
• Supervise children's brushing until good habits are established.  
• Children under 2 years: ask a dentist.

For clean and healthy teeth: See  your dentist on a regular basis for a professional cleaning.  Use dental floss daily.

Questions or Comments?

Call toll-free 1-866-373-7374 or visit us at www.drfresh.com and www.binaca.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BINACA ANTICAVITY FLOURIDE PEPPERMINT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64893-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64893-001-24	24 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2010
2	NDC: 64893-001-42	1 in 1 BOX	05/04/2010
2		119 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/04/2010

Labeler - Dr. Fresh, Inc (078508990)