ORAPRO FLUORIDE ANTICAVITY- fluoride toothpaste paste, dentifrice

OraPro Fluoride Anticavity by

Drug Labeling and Warnings

OraPro Fluoride Anticavity by is a Otc medication manufactured, distributed, or labeled by Protegera, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

ORAPRO FLUORIDE ANTICAVITY 
fluoride toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83610-1060
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83610-1060-1	1 in 1 CARTON	06/30/2025
1		147 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 Drug	M021	06/30/2025

Labeler - Protegera, Inc. (119027090)