ZOHAR FLUORIDE ANTI CAVITY COOLMINT FLAVOUR- sodium monofluorophosphate paste

Zohar Fluoride Anti Cavity Coolmint Flavour by

Drug Labeling and Warnings

Zohar Fluoride Anti Cavity 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 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, Water, Glycerin, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Sodium Saccharin. 

Label

INGREDIENTS AND APPEARANCE

ZOHAR FLUORIDE ANTI CAVITY COOLMINT FLAVOUR 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84045-004
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84045-004-00	1 in 1 CARTON	03/15/2024
1		113 g in 1 TUBE; Type 0: Not a Combination Product

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)