Freshmax Fluoride Regular Flavor (Sodium Monofluorophosphate) Paste [International Wholesale Inc] -

FRESHMAX FLUORIDE REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE [INTERNATIONAL WHOLESALE INC]
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NDC	52862-500-00
Set ID	499bb6c3-a6d7-2a5d-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	International Wholesale Inc
Generic Name
Product Class
Product Number
Application Number	PART355

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	02/27/2017

Labeler - International Wholesale Inc (161872676)

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