Orazen
FDA Label NDC 71927-102

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Orazen Inc for the product Orazen (NDC 71927-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, description, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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