ZOHAR TOOTHPASTE REGULAR MINT

Main information

  • Trade name:
  • ZOHAR TOOTHPASTE REGULAR MINT- sodium monofluorophosphate paste, dentifrice
  • Administration route:
  • DENTAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ZOHAR TOOTHPASTE REGULAR MINT- sodium monofluorophosphate paste, dentifrice
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Anticavity Aids in the prevention of dental cavities

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 55754-123-01
  • Last update:
  • 29-05-2019

Summary of Product characteristics: dosage, interactions, side effects

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.

----------

Drug Facts

Active Ingredients

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

Purpos e

Anticavity

Us es

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

Ques tions ?

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55754-123

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

11.5 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)

GLYCERIN (UNII: PDC6 A3C0 OX)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

Broom Lane Enterprises

CARVO NE, ( +/-) - (UNII: 75GK9 XIA8 I)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55754-123-0 1

1 in 1 CARTON

1

113.4 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 11

Labeler -

Broom Lane Enterprises (211243172)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Suzho u City Jinmao Daily Chemicals Co ., Ltd

5476 6 418 5

ma nufa c ture

Revised: 2/2011