ZOHAR TOOTHPASTE REGULAR MINT- sodium monofluorophosphate paste, dentifrice

Zohar Toothpaste by

Drug Labeling and Warnings

Zohar Toothpaste by is a Otc medication manufactured, distributed, or labeled by Broom Lane Enterprises, Suzhou City Jinmao Daily Chemicals Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

ZOHAR TOOTHPASTE  REGULAR MINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55754-123
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: 55754-123-01	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