Orapro Fluoride Anticavity Paste, Dentifrice
FDA Label NDC 83610-1060
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Protegera, Inc. for the product Orapro Fluoride Anticavity (NDC 83610-1060). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, use, warnings, directions, inactive ingredients:, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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.
Principal Display Panel
OraPro Paste NDC 83610-1060-1
Advanced Biofilm Removal
Fluoride AnitCavity Toothpaste
NET WT 5.2 OZ (147g)
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