DR. FRESH ORAL CARE- sodium monofluorophosphate paste
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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Dr. Fresh Oral Care Kit

Drug Facts

Active Ingredient

Sodium Monofluorophosphate (0.76%)

Purpose

Anticavity

Use

helps protect against cavities.

Warnings

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

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

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

Package Labeling:

DR. FRESH ORAL CARE
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64893-320
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:64893-320-01	1 in 1 PACKAGE	05/04/2010	06/30/2021
1		24 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	06/30/2021

Labeler - Dr. Fresh, LLC (117376803)

Revised: 9/2021

Document Id: 3b95fd39-30a1-4655-9e81-fea2679daf0c

Set id: 70c4d967-78b4-405e-bedb-b699ada3f5fb

Version: 6

Effective Time: 20210922

Dr. Fresh, LLC