Zohar Toothpaste Regular Mint

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 11.5mg in 1g
Labeler: Broom Lane Enterprises
NDC Code: 55754-123

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 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
  • 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

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/75ml

ZOHAR TOOTHPASTE  REGULAR MINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55754-123
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE11.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
WATER 
GLYCERIN 
HYDRATED SILICA 
SODIUM LAURYL SULFATE 
SILICON DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
CARVONE, (+/-)- 
SACCHARIN SODIUM 
METHYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:55754-123-011 TUBE (TUBE) 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/FEIOperations
Suzhou City Jinmao Daily Chemicals Co., Ltd547664185manufacture

Revised: 02/2011
 
Broom Lane Enterprises

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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