Label: PROSYS 5000- sodium fluoride paste, dentifrice
- NDC Code(s): 66975-501-04
- Packager: Benco Dental
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated November 2, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions: Use As Directed
This prescription dentifrice is recommended for adults and
pediatric patients six years and older.
• Apply a thin ribbon of PRO-SYS Professional along the
length of the toothbrush no more than "pea size" total
dose. Brush for two minutes.
• After brushing:
ADULTS-Expectorate; do not eat or drink for 30 minutes.
CHILDREN SIX YEARS OF AGE OR OLDER-Expectorate
and rinse mouth with water.
• Use at bedtime in place of your regular toothpaste or as
directed by your dental professional. - OTHER SAFETY INFORMATION
- Package Label - ProSys 5000
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INGREDIENTS AND APPEARANCE
PROSYS 5000
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66975-501 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 1.1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) XYLITOL (UNII: VCQ006KQ1E) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MINT (UNII: FV98Z8GITP) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) Product Characteristics Color Score Shape Size Flavor VANILLA (MINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66975-501-04 112 g in 1 TUBE; Type 0: Not a Combination Product 10/13/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/13/2023 Labeler - Benco Dental (015108087) Registrant - Benco Dental (015108087)
