ZOHAR ANTI CAVITY MOUTHWASH COOLMINT FLAVOUR- sodium fluoride liquid

Zohar Anti Cavity Mouthwash Coolmint Flavour by

Drug Labeling and Warnings

Zohar Anti Cavity Mouthwash Coolmint Flavour by is a Otc medication manufactured, distributed, or labeled by ZOHAR KOSHER LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Adults and children 6 years of age and older:
• use once a day after brushing your teeth with a toothpaste 
• vigorously swish 10 ml (2teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
• do not swallow the rinse 
• do not eat or drink for 30 minutes after rinsing
• instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
• supervise children as necessary untill capable of using without supervision.
• Children under 6 years of age:consult a dentist or doctor.

Inactive ingredients

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

Label

INGREDIENTS AND APPEARANCE

ZOHAR ANTI CAVITY MOUTHWASH COOLMINT FLAVOUR 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84045-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84045-001-00	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	03/15/2024

Labeler - ZOHAR KOSHER LIMITED (221033261)