OTC Labels

Over the Counter Medications

OTC Medication Information: Zohar Toothpaste Regular Mint

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.

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

HELPS FIGHT TOOTH DECAY

Net Wt. 4oz/75ml

Zohar Fluoride Toothpaste Regular Mint
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE 11.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
WATER
GLYCERIN
HYDRATED SILICA
SODIUM LAURYL SULFATE
SILICON DIOXIDE
CARBOXYMETHYLCELLULOSE SODIUM
CARVONE, (+/-)-
SACCHARIN SODIUM
METHYLPARABEN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55754-123-01 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 113.4 g in 1 TUBE This package is contained within the CARTON (55754-123-01)
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 Operations
Suzhou City Jinmao Daily Chemicals Co., Ltd 547664185 manufacture

Revised: 02/2011 Broom Lane Enterprises