Label: ZOHAR TOOTHPASTE COOL MINT- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 55754-122-01 - Packager: Broom Lane Enterprises
- 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 February 28, 2011
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- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- do not swallow
- supervise children as necessary until capable of using without supervision.
adults and children 6 years of age and older
Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
children 6 to 12 years
instruct in good brushing and rinsing habits(to minimise swallowing)
children under 6 years
do not use unless directed by dentist or doctor
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INGREDIENTS AND APPEARANCE
ZOHAR TOOTHPASTE COOL MINT
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55754-122 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 11.5 mg in 1 g Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CARVONE, (+/-)- (UNII: 75GK9XIA8I) SACCHARIN SODIUM (UNII: SB8ZUX40TY) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55754-122-01 1 in 1 CARTON 1 113.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/28/2011 Labeler - Broom Lane Enterprises (211243172) Establishment Name Address ID/FEI Business Operations Suzhou City Jinmao Daily Chemicals Co., Ltd 547664185 manufacture