Label: PARODONTAX COMPLETE PROTECTION- stannous fluoride paste
- NDC Code(s): 0135-0627-01, 0135-0627-02, 0135-0627-03, 0135-0627-04
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 9, 2024
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- Active ingredient
- Purposes
- Uses
- Warnings
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Directions
- adults and children 2 years of age and older:
- apply toothpaste onto a toothbrush.
- brush teeth thoroughly, preferably after each meal at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
- to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
children under 2 years of age:Consult a dentist or doctor.
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- Inactive ingredients
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INGREDIENTS AND APPEARANCE
PARODONTAX COMPLETE PROTECTION
stannous fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0627 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0627-02 1 in 1 CARTON 11/01/2018 1 96.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0135-0627-03 1 in 1 CARTON 01/06/2020 2 65.2 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:0135-0627-01 1 in 1 CARTON 04/01/2020 3 23 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:0135-0627-04 23 g in 1 TUBE; Type 0: Not a Combination Product 12/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 11/01/2018 Labeler - Haleon US Holdings LLC (079944263)