DR. FRESH ORAL CARE- sodium monofluorophosphate paste

DR. FRESH ORAL CARE by

Drug Labeling and Warnings

DR. FRESH ORAL CARE 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

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:

INGREDIENTS AND APPEARANCE

DR. FRESH ORAL CARE 
sodium monofluorophosphate paste

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