ZOHAR FLUORIDE ANTI-CAVITY REGULAR MINT FLAVOUR- sodium monofluorophosphate paste

Zohar Fluoride Anti-Cavity Regular Mint Flavour by

Drug Labeling and Warnings

Zohar Fluoride Anti-Cavity Regular Mint 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, Glycerin, Water, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Benzoate, Spearmint Oil, Laevo Carvone, Flavor, Sodium Saccharin.

Package Labeling:

INGREDIENTS AND APPEARANCE

ZOHAR FLUORIDE ANTI-CAVITY REGULAR MINT FLAVOUR 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84045-005
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)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SPEARMINT OIL (UNII: C3M81465G5)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84045-005-00	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)