Label: GOBY PEPPERMINT- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 81788-001-00 - Packager: BGLG, Inc.
- 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 April 19, 2021
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- Active Ingredients
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- Inactive Ingredients
- Package Labeling:
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INGREDIENTS AND APPEARANCE
GOBY PEPPERMINT
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81788-001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.4 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) METHYL SALICYLATE (UNII: LAV5U5022Y) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81788-001-00 99 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 05/01/2021 Labeler - BGLG, Inc. (074391154)