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  5. Label Information: Burkhart

FDA Label for Burkhart

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT:
    2. PURPOSE:
    3. USES:
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. WARNINGS:
    6. DIRECTIONS:
    7. OTHER INFORMATION:
    8. INACTIVE INGREDIENTS:
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burkhart Product Label

The following document was submitted to the FDA by the labeler of this product Burkhart Dental Supply 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:



Stannous Fluoride 0.4%


Purpose:



Fluoride preventive treatment gel.


Uses:



  • Home Care is a stable, water-free fluoride gel for home use.
  • Aids in the prevention of dental decay.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Warnings:



  • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
  • This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.

Directions:



Adults and children 6 years of age and older: Twist off cap and remove foil seal. Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: consult a dentist or doctor.


Other Information:



Store at controlled room temperature 59° - 86°F (15° - 30°C)


Inactive Ingredients:



Carbopol, Flavor, Glycerine, Malic Acid, Sodium Carboxymethylcellulose, Water, Xanthan Gum.


Package Label.Principal Display Panel




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