made by dentists for kids monster slime

made by dentists for kids monster slime
SPL v2
SPL
SPL Set ID 16ef3c05-572c-f568-e063-6394a90a23b8
Route
dental
Published
Effective Date 2024-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.5 mg)
Inactive Ingredients
sorbitol water hydrated silica glycerin xylitol carboxymethylcellulose sodium, unspecified cocamidopropyl betaine potassium sorbate stevia rebaudiuna leaf bixa orellana seed

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-01-01

Purpose

Anticavity 

Description

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)


Medication Information

Purpose

Anticavity 

Description

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Use:

Aids in the prevention of cavities.

Label

Drug Facts

Directions:
  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing), and only use a pea size amount.
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.
Active Ingredient:

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients:

Sorbitol, Water (Aqua), Hydrated Silica, Glycerin, Xylitol, Cellulose Gum, Cocamidopropyl Betaine, Potassium Sorbate, Stevia Rebaudiana Leaf Extract, Chlorophyllin-Copper Extract, Bixa orellana Seed Extract

Questions Or Comments?

+ 1 (646) 980-6461

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

If more than used for brushing is accidentlly swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose

Anticavity 

Use:

Aids in the prevention of cavities.

Label

Drug Facts

Directions:
  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing), and only use a pea size amount.
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.
Active Ingredient: (Active ingredient:)

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients: (Inactive ingredients:)

Sorbitol, Water (Aqua), Hydrated Silica, Glycerin, Xylitol, Cellulose Gum, Cocamidopropyl Betaine, Potassium Sorbate, Stevia Rebaudiana Leaf Extract, Chlorophyllin-Copper Extract, Bixa orellana Seed Extract

Questions Or Comments? (Questions or comments?)

+ 1 (646) 980-6461

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 accidentlly swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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