BINACA ANTICAVITY FLOURIDE PEPPERMINT- sodium monofluorophosphate paste, dentifrice
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.

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Binaca Anticavity Fluoride Toothpaste Peppermint

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

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64893-001-24	24 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2010	12/31/2019
2	NDC:64893-001-42	1 in 1 BOX	05/04/2010	12/31/2019
2		119 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/04/2010	12/31/2019

Labeler - Dr. Fresh, LLC (117376803)

Revised: 9/2021

Document Id: ee354f15-d8a6-427e-b15f-e22bbafa69de

Set id: fc82ba5a-db82-46c1-8509-f94f01358397

Version: 12

Effective Time: 20210922

Dr. Fresh, LLC