FRESHMAX FLUORIDE MINTY FLAVOR- sodium monofluorophosphate paste 
International Wholesale Inc

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FreshMax Fluoride Toothpaste Minty Flavor

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

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

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:

Label2

FRESHMAX FLUORIDE MINTY FLAVOR 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-501
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION76 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52862-501-001 in 1 BOX02/27/2017
1181 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02102/27/2017
Labeler - International Wholesale Inc (161872676)

Revised: 10/2023
Document Id: 08325f65-2d2d-9ffc-e063-6294a90a3a8c
Set id: 499bbbbc-d301-33b3-e054-00144ff88e88
Version: 5
Effective Time: 20231020
 
International Wholesale Inc