ZOHAR FLUORIDE ANTI-CAVITY REGULAR MINT FLAVOUR- sodium monofluorophosphate paste 
ZOHAR KOSHER LIMITED

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Zohar Fluoride Anti-Cavity Toothpaste Regular Mint Flavour

Drug Facts

Active ingredients

Sodium Monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

Do not use if

irritation occurs and persists.

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 immediately.

Directions

 • Do not swallow • Supervise children as necessary until capable of using without supervision.

 Adults and children 2 years of age and older Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.
 Children under 6 years Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
 Children under 2 years Ask a dentist or physician

Inactive ingredients

Calcium Carbonate, Glycerin, Water, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Benzoate, Spearmint Oil, Laevo Carvone, Flavor, Sodium Saccharin.

Package Labeling:

Outer Package2Inner Package2

ZOHAR FLUORIDE ANTI-CAVITY REGULAR MINT FLAVOUR 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84045-005
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SPEARMINT OIL (UNII: C3M81465G5)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84045-005-001 in 1 CARTON03/15/2024
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02103/15/2024
Labeler - ZOHAR KOSHER LIMITED (221033261)

Revised: 2/2024
Document Id: 126388a4-51c9-8e9e-e063-6294a90ac718
Set id: 17a786df-1f47-40ee-8370-fc6b9c7ec7c3
Version: 1
Effective Time: 20240227
 
ZOHAR KOSHER LIMITED