Prime Tooth Care Toothpaste, Hami Melon

Prime Tooth Care Toothpaste, Hami Melon
SPL v2
SPL
SPL Set ID 0028f88d-a9fe-4cfa-a6c6-168f9689b5f6
Route
DENTAL
Published
Effective Date 2025-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.5 mg)
Inactive Ingredients
Water Hydrated Silica Glycerin Sodium Lauroyl Sarcosinate Xanthan Gum Menthol Sodium Benzoate Carboxymethylcellulose Saccharin Sodium Xylitol Sodium Pyrophosphate Asian Ginseng Hydrogen Peroxide Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-31
Description

Sodium fluoride 0.25% (1100PPM) 

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.25% (1100PPM) 

Use

helps protect against cavities

Warnings

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor. • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

• Supervise children as necessary until capable of using without supervision. • Children under 2 years of age: Consult a dentist or doctor.

Drug Facts

Active Ingredient

Sodium fluoride 0.25% (1100PPM) 

Package Labeling:

Inactive Ingredients

Sorbitol, Aqua, Hydrated Silica, Glycerin, Sodium Lauroyl Sarcosinate, Fragrance/ Flavor, Nano-Hydroxyapatite, Xanthan Gum, Menthol, Sodium Benzoate, Carboxymethyl Cellulose, Sodium Saccharin, Xylitol, Sodium Pyrophosphate, Red Dates Extract, Ginseng Extract, Hydrogen Peroxide (PVP - H202).

When Using This Product
  • Do not swallow
  • Do not use in eye area
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 right away.

Structured Label Content

Use

helps protect against cavities

Purpose

Anticavity

Warnings

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor. • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

• Supervise children as necessary until capable of using without supervision. • Children under 2 years of age: Consult a dentist or doctor.

Drug Facts

Active Ingredient

Sodium fluoride 0.25% (1100PPM) 

Package Labeling:

Inactive Ingredients

Sorbitol, Aqua, Hydrated Silica, Glycerin, Sodium Lauroyl Sarcosinate, Fragrance/ Flavor, Nano-Hydroxyapatite, Xanthan Gum, Menthol, Sodium Benzoate, Carboxymethyl Cellulose, Sodium Saccharin, Xylitol, Sodium Pyrophosphate, Red Dates Extract, Ginseng Extract, Hydrogen Peroxide (PVP - H202).

When Using This Product (When using this product)
  • Do not swallow
  • Do not use in eye area
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 right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:26.282410 · Updated: 2026-03-14T23:12:38.341862