BEE SMART

Main information

  • Trade name:
  • BEE SMART- sodium monofluorophosphate paste, dentifrice
  • Composition:
  • SODIUM MONOFLUOROPHOSPHATE 7.6 mg in 1 g
  • Administration route:
  • DENTAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BEE SMART- sodium monofluorophosphate paste, dentifrice
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Anticavity Regular brushing with Fluoride toothpaste helps protect teeth and roots against cavities.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 68747-6033-1
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

BEE SMART- sodium monofluorophosphate paste, dentifrice

Dabur India Limited

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.

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Drug Facts

Active Ingredients:

Sodium Monofluorophosphate 0.76%

(Total Fluoride Content – 1000 ppm Approx.)

Purpos e

Anticavity

Us es :

Regular brushing with Fluoride toothpaste helps protect teeth and roots against cavities.

Warnings :

Keep out of reach of children under 6 years of age.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center

immediately.

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 :

Calcium Carbonate, Water, Sorbitol, Precipitated Silica, Sodium Lauryl Sulphate, Flavor, Sodium

Carboxy Methyl Cellulose, Sodium Silicate, Tetra Sodium Pyrophosphate, Sodium Saccharin, Methyl

Paraben, Titanium Dioxide, Poly Ethylene Glycol 400, Propyl Paraben.

Principal Display Panel – Carton Label

Bee Smart™

QUALITY & VALUE

TOOTHPASTE

With Fluoride Anticavity Protection

Fresh Mint Flavor

NET WT 6.4 OZ (181g)

Principal Display Panel – Tube Label

Bee Smart™

QUALITY & VALUE

TOOTHPASTE

With Fluoride Anticavity Protection

Fresh Mint Flavor

NET WT 6.4 OZ (181g)

BEE SMART

sodium monofluorophosphate paste, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 747-6 0 33

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION -

UNII:Q8 0 VPU40 8 O)

SODIUM

MONOFLUOROPHOSPHATE

7.6 mg

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

SO DIUM PYRO PHO SPHATE (UNII: O3528 6 4B8 Z)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Dabur India Limited

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

MINT (MINT)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 747-6 0 33-1

1 in 1 CARTON

1

18 1 g in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 2/28 /20 12

Labeler -

Dabur India Limited (650319218)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dabur India Limited

6 50 319 218

MANUFACTURE(6 8 747-6 0 33)

Revised: 8/2008