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  5. Label Information: Orabrite

FDA Label for Orabrite

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USE
    5. WARNINGS
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. PACKAGE LABEL

Orabrite Product Label

The following document was submitted to the FDA by the labeler of this product Oraline, 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.

Active Ingredient



DRUG FACTS

ACTIVE INGREDIENT:

Sodium Fluoride 0.22%

(Total Fluoride Content - 1000 ppm approx.)


Purpose



PURPOSE: Anticavity Toothpaste.


Keep Out Of Reach Of Children



WARNINGS: 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 immediately.


Use



USE: Helps protect against cavities.


Warnings



WARNINGS: 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 immediately.


Directions



DIRECTIONS:

Adults and children 2 tears 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 god 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



INACTIVE INGREDIENTS:

Hydrated Silica, Sorbitol, Deionized Water, Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Lauryl Sulfate, Sodium Carboxymethylcellulose, Flavor, Sodium Saccharin.


Package Label



Distributed by Oraline Inc., 823 NYS RT 13, Cortland, N.Y. 13045

OraBrite

Mint Flavor with Fluoride

NET WT 1.50 oz.

Mfg. Date and Batch No. on crimp.

Product of China, produced for Oraline. 888-296-6730.  www.oraline.net

Oraline OraBrite 2 Label - Oraline OraBrite2

Oraline OraBrite 2 Label - Oraline OraBrite2



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