MADE BY DENTISTS ULTRA WHITENING FRESH MINT- sodium fluoride paste 
MADE BY DENTISTS INC

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Made by Dentists Ultra Whitening Toothpaste Fresh Mint

Drug Facts

Active ingredient:

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity 

Use:

Aids in the prevention of cavities.

Warnings:

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

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

Directions:

Inactive ingredients:

Water (Aqua), Sorbitol, Hydrated Silica, Xylitol, Flavor, Cocamidopropyl Betaine, Cellulose Gum, Pentasodium Triphosphate, Titanium Dioxide, Sordium Saccharin, Potassium Sorbate, Hydrogen Peroxide, Sodium Bicarbonate

Questions or comments?

+ 1 (646) 980-6461

Label 75065-027-06

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Label 75065-027-07

LabelLabel tube

MADE BY DENTISTS ULTRA WHITENING FRESH MINT 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75065-027
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
XYLITOL (UNII: VCQ006KQ1E)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75065-027-061 in 1 CARTON02/22/2024
1120 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:75065-027-071 in 1 CARTON02/22/2024
220 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02102/22/2024
Labeler - MADE BY DENTISTS INC (117405870)

Revised: 3/2024
Document Id: 13b86adc-f15f-de02-e063-6294a90a4ac4
Set id: dbce2aba-48db-4e78-bf79-74f34868ee37
Version: 2
Effective Time: 20240315
 
MADE BY DENTISTS INC