Label: BEE SMART- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 68747-6033-1 - Packager: Dabur India Limited
- 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 August 25, 2008
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- SPL UNCLASSIFIED SECTION
- Active Ingredients:
- Purpose
- Uses:
- Warnings:
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DOSAGE & ADMINISTRATION
Directions:
Adult and children 2 years 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 yrs To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established. Children under 2 yrs Ask a dentist or physician - Ingredients:
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BEE SMART
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68747-6033 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 7.6 mg in 1 g Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color Score Shape Size Flavor MINT (MINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68747-6033-1 1 in 1 CARTON 1 181 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/28/2012 Labeler - Dabur India Limited (650319218) Establishment Name Address ID/FEI Business Operations Dabur India Limited 650319218 MANUFACTURE(68747-6033)