Label: ORBITOL FLUORIDE TOOTHPASTE WITH BAKING SODA- sodium monofluorophosphate paste
- NDC Code(s): 62685-230-04
- Packager: tropical degil cosmetics industries ltd
- 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 January 5, 2023
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- Active ingredient
- Purpose
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- WARNINGS
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Directions
- Adults and children 6 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
- Children under 6 years of age: Do not use unless directed by a dentist or doctor.
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
ORBITOL FLUORIDE TOOTHPASTE WITH BAKING SODA
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62685-230 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) LIMONENE, (+)- (UNII: GFD7C86Q1W) CALCIUM CARBONATE (UNII: H0G9379FGK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) BENZOIC ACID (UNII: 8SKN0B0MIM) SODIUM LAURYL SULFATE (UNII: 368GB5141J) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) ZINC CITRATE (UNII: K72I3DEX9B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62685-230-04 1 in 1 BOX 09/27/2021 1 145 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 09/27/2021 Labeler - tropical degil cosmetics industries ltd (600437230) Establishment Name Address ID/FEI Business Operations tropical degil cosmetics industries ltd 600437230 manufacture(62685-230)