Label: ORBITOL MINT FLAVORED FLUORIDE TOOTHPASTE- sodium monofluorophosphate paste
- NDC Code(s): 62685-231-04
- Packager: tropical degil cosmetics industries ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 10, 2024
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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
- Other information
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INGREDIENTS AND APPEARANCE
ORBITOL MINT FLAVORED FLUORIDE TOOTHPASTE
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62685-231 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 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62685-231-04 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 Drug M022 09/27/2021 Labeler - tropical degil cosmetics industries ltd (600437230) Establishment Name Address ID/FEI Business Operations tropical degil cosmetics industries ltd 600437230 manufacture(62685-231)