ZOHAR ANTI CAVITY MOUTHWASH COOLMINT FLAVOUR- sodium fluoride liquid 
ZOHAR KOSHER LIMITED

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Zohar Anti-Cavity Mouthwash Coolmint Flavour

Drug Facts

Active ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Water, Xylitol, Glycerin, Sodium Benzoate, Flavor, Sodium Citrate, Sodium Saccharin, Citric Acid, Poloxamer 407, FD&C Blue #1.

Label

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ZOHAR ANTI CAVITY MOUTHWASH COOLMINT FLAVOUR 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84045-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84045-001-00500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2024
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: 12627ada-c810-14b7-e063-6394a90af039
Set id: a35355f3-c96d-4085-b4da-7e695dc73888
Version: 1
Effective Time: 20240227
 
ZOHAR KOSHER LIMITED