Label: ZOHAR FLUORIDE ANTI-CAVITY REGULAR MINT FLAVOUR- sodium monofluorophosphate paste
- NDC Code(s): 84045-005-00
- Packager: ZOHAR KOSHER LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 27, 2024
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- Drug Facts
- Active ingredients
- Use
- Warnings
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Directions
• Do not swallow • Supervise children as necessary until capable of using without supervision.
Adults and children 2 years of age and older Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician. Children under 6 years Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) Children under 2 years Ask a dentist or physician - Inactive ingredients
- Package Labeling:
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INGREDIENTS AND APPEARANCE
ZOHAR FLUORIDE ANTI-CAVITY REGULAR MINT FLAVOUR
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84045-005 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 7.6 mg in 1 g Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SODIUM BENZOATE (UNII: OJ245FE5EU) SPEARMINT OIL (UNII: C3M81465G5) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84045-005-00 1 in 1 CARTON 03/15/2024 1 113 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 M021 03/15/2024 Labeler - ZOHAR KOSHER LIMITED (221033261)