ORAPRO FLUORIDE ANTICAVITY- fluoride toothpaste paste, dentifrice 
Protegera, Inc.

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OraPro Fluoride Anticavity Toothpaste

Drug Facts 

Active ingredient

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

Purpose 

Anticavity

Use

Helps protect agaisnt cavities

Warnings 

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

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

Directions

adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing habits (to minimize swallowing). Supervise children as nessary until capable of using without supervision. Children under 2 years ask a dentist or physician

Inactive ingredients:

 Glycerol, Water, Hydrated Silica, Crystalline Cellulose, Cellulose, Flavor, Cocamidopropyl Betaine, Sodium Gluconate, Carbomer, Sodium Benzoate, PVM/MA Copolymer, Poloxamer 407, Xanthan Gum, Sodium Hydroxide, Benzyl Alcohol.

Questions or Comments ?
1-855-255-6722
www.OraProPaste.com

Principal Display Panel 

OraPro Paste    NDC 83610-1060-1

Advanced Biofilm Removal

Fluoride AnitCavity Toothpaste

NET WT 5.2 OZ (147g)

OraPro 550202S Carton

OraPro 250202S Tube

ORAPRO FLUORIDE ANTICAVITY 
fluoride toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83610-1060
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CELLULOSE GUM (UNII: K679OBS311)  
CALCIUM CARBOXYMETHYL CELLULOSE (UNII: UTY7PDF93L)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
METHYL VINYL ETHER AND MALEIC ACID COPOLYMER (1750000 WAMW) (UNII: 9F20VSM0VU)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83610-1060-11 in 1 CARTON06/30/2025
1147 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02106/30/2025
Labeler - Protegera, Inc. (119027090)

Revised: 7/2025
Document Id: 3995ff67-0795-cc1d-e063-6394a90af7ff
Set id: 93b0181c-e29f-42f4-80f5-366463b68f09
Version: 4
Effective Time: 20250710
 
Protegera, Inc.