ZOHAR FLUORIDE ANTI CAVITY COOLMINT FLAVOUR- sodium monofluorophosphate paste 
ZOHAR KOSHER LIMITED

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Zohar Fluoride Anti-Cavity Toothpaste Coolmint 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

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

Inactive ingredients

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

Label

Label.jpgInner Label.jpg

ZOHAR FLUORIDE ANTI CAVITY COOLMINT FLAVOUR 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84045-004
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)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84045-004-001 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: 12633511-5cda-51f8-e063-6394a90a4173
Set id: 3a5c7dd2-a6c7-424d-b28d-000922df8b5b
Version: 1
Effective Time: 20240227
 
ZOHAR KOSHER LIMITED