FDA Label for Orazen

View Indications, Usage & Precautions

Orazen Product Label

The following document was submitted to the FDA by the labeler of this product Orazen Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient                               

Sodium Monofluorophosphate 0.76%


Otc - Purpose



Purpose
Anti-Cavity Toothpaste


Indications & Usage



Use: Helps prevent against cavities


Otc - Keep Out Of Reach Of Children



 Keep out of reach of children under 6 years of age.


Warnings



Warnings: If you accidentally swallow more than used for brushing,get medical help or contact a Poison Control Center immediately.


Dosage & Administration



Directions: adults and children 2yrs.and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. To minimize swallowing use a pea sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 yrs.:ask a dentist


Inactive Ingredient



Inactive Ingredients: Sorbitol, Hydrated Silica, Water, Peg-8, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Saccharin, Trisodium Phospate, Mica, Sodium Benzoate, CI 73015


Description



Orazen

Orazen Inc

Somerset, NJ 08873

Questions 888-349-7897

[email protected]

Made in China/Hecho en China

Fabrique en Chine


Package Label.Principal Display Panel



Ora-Zen

Kids' Dental Care Kit

Kids


Kit Contains:

  • Kids' Flexi Toothbrush
  • 4 Flossers
  • Kids' Toothpaste Bubblegum Flavor

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