prime tooth care toothpaste, cream strawberries

prime tooth care toothpaste, cream strawberries
SPL v2
SPL
SPL Set ID 7b4328bd-5d2d-40ca-8322-5e818e1babf9
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
sorbitol water hydrated silica glycerin sodium lauroyl sarcosinate xanthan gum menthol sodium benzoate carboxymethylcellulose saccharin sodium xylitol sodium pyrophosphate asian ginseng hydrogen peroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-08-31

Purpose

Anticavity

Description

Sodium fluoride 0.25% (1100PPM) 


Medication Information

Warnings

Purpose

Anticavity

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.

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).

Description

Sodium fluoride 0.25% (1100PPM) 

Use

helps protect against cavities

Drug Facts

Active Ingredient

Sodium fluoride 0.25% (1100PPM) 

Package Labeling:

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

Warnings

Purpose

Anticavity

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.

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).

Use

helps protect against cavities

Drug Facts

Active Ingredient

Sodium fluoride 0.25% (1100PPM) 

Package Labeling:

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

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