ZOHAR FLUORIDE ANTI CAVITY FRESH MINT FLAVOR- sodium monofluorophosphate paste 
ZOHAR KOSHER LIMITED

----------

Zohar Fluoride Anti-Cavity Toothpaste Fresh Mint Flavor

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. 

Package Labeling:

Label06Label07

ZOHAR FLUORIDE ANTI CAVITY FRESH MINT FLAVOR 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84045-006
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:84045-006-001 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: 1263b2b4-ddfa-7aff-e063-6394a90ae98a
Set id: f36f8b13-c5d2-4dfa-ae40-d957e49e701a
Version: 1
Effective Time: 20240227
 
ZOHAR KOSHER LIMITED