FRESHMAX FLUORIDE REGULAR FLAVOR- sodium monofluorophosphate paste

FreshMax Fluoride Regular Flavor by

Drug Labeling and Warnings

FreshMax Fluoride Regular Flavor by is a Otc medication manufactured, distributed, or labeled by International Wholesale Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Sodium Monofluorophosphate 0.76%

(Available fluoride content:1000ppm)

Purpose

Anticavity

Uses

Regular brushing with Fluoride toothpaste helps protect teeth and roots against cavities.

Warnings

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

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age or older: Brush teeth thoroughly, preferable after each meal or at least twice a day, or as directed by a dentist or doctor.
Children under 6 years: Instruct children under 6 years of age to use a pea size amount. Supervise child’s brushing and rinsing (to minimize swallowing.)
Children under 2 years of age: Consult a dentist or physician.

Inactive Ingredients

Water, Sorbitol, Polyethylene Glycol 400, Sodium Carboxymethylcellulose, Silica, Gypsum Powder, Sodium Saccharin, Sodium Lauryl Alcohol, Flavor, Methyl Paraben, Propylparaben, Color: Bright Blue.

Other Information:

Lot No. & Expiration Date: See box or crimp of tube.

Package Labeling:

INGREDIENTS AND APPEARANCE

FRESHMAX FLUORIDE REGULAR FLAVOR 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52862-500
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	76 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYL SALICYLATE (UNII: LAV5U5022Y)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52862-500-00	1 in 1 BOX	02/27/2017
1		181 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	02/27/2017

Labeler - International Wholesale Inc (161872676)