ZOHAR TOOTHPASTE REGULAR MINT- sodium monofluorophosphate paste, dentifrice 
Broom Lane Enterprises

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 monofluorphosphate 1.15% (1500 ppm/ 0.15% w/v fluoride ion)

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities

Warnings


  • keep out of reach of children under 6 years of age.
  • If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

Directions

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

Calcium Carbonate, Water, Glycerine, Hydrated Silica, Sodium Lauryl Sulphate, Silica, Cellulose gum, Flavour, Carvone, Sodium Saccharin, Methylparaben, Limonene

Questions?

call 718 256 9100
you may also report serious side effects to this phone number

Principal Display Panel

Zohar
FLUORIDE
TOOTHPASTE


REGULAR MINT

HELPS FIGHT TOOTH DECAY

Net Wt. 4oz/75mlZohar Fluoride Toothpaste Regular Mint

ZOHAR TOOTHPASTE  REGULAR MINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55754-123
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE11.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55754-123-011 in 1 CARTON
1113.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/28/2011
Labeler - Broom Lane Enterprises (211243172)
Establishment
NameAddressID/FEIBusiness Operations
Suzhou City Jinmao Daily Chemicals Co., Ltd547664185manufacture

Revised: 2/2011
Document Id: 7fb0ecea-c5ac-4983-acf1-b4031a9cd110
Set id: 9174ef4b-0c42-480b-983c-adadd1e3a291
Version: 1
Effective Time: 20110228
 
Broom Lane Enterprises