Label: SMILEBAR WHITENING- sodium fluoride paste, dentifrice
-
Contains inactivated NDC Code(s)
NDC Code(s): 73449-001-01 - Packager: Smilebar
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 8, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- Package Labeling
-
INGREDIENTS AND APPEARANCE
SMILEBAR WHITENING
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73449-001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.43 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM BICARBONATE (UNII: 8MDF5V39QO) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) ZINC CITRATE (UNII: K72I3DEX9B) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73449-001-01 96 g in 1 TUBE; Type 0: Not a Combination Product 11/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 11/15/2019 Labeler - Smilebar (065798164) Registrant - Smilebar (065798164)