zohar fluoride anti-cavity toothpaste coolmint flavour

zohar fluoride anti-cavity toothpaste coolmint flavour
SPL v1
SPL
SPL Set ID 3a5c7dd2-a6c7-424d-b28d-000922df8b5b
Route
dental
Published
Effective Date 2024-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (7.6 mg)
Inactive Ingredients
calcium carbonate water glycerin hydrated silica sodium lauryl sulfate carboxymethylcellulose sodium, unspecified sodium benzoate saccharin sodium

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-03-15
Purpose

Anticavity

Description

Sodium Monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Medication Information

Warnings

Do not use if irritation occurs and persists.

Purpose

Anticavity

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. 

Description

Sodium Monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Use

Aids in the prevention of dental cavities

Label

Drug Facts

Active Ingredients

Sodium Monofluorophosphate 0.76% (0.1% w/v fluoride ion)

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.

Structured Label Content

Warnings

Do not use if irritation occurs and persists.

Purpose

Anticavity

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 (Inactive ingredients)

Calcium Carbonate, Water, Glycerin, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Sodium Saccharin. 

Use

Aids in the prevention of dental cavities

Label

Drug Facts

Active Ingredients (Active ingredients)

Sodium Monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Keep Out of Reach of Children Under 6 Years of Age. (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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:51.866269 · Updated: 2026-03-14T23:02:39.250584