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  5. Label Information: Biotene

FDA Label for Biotene

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(FRESH MINT ORIGINAL)
    2. ACTIVE INGREDIENT (GENTLE MINT)
    3. PURPOSE
    4. USE
    5. KEEP OUT OF REACH OF CHILDREN 12 YEARS AND UNDER.
    6. WHEN USING THIS PRODUCT,
    7. KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE.
    8. DIRECTIONS (FRESH MINT ORIGINAL)
    9. DIRECTIONS (GENTLE MINT)
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS (FRESH MINT ORIGINAL)
    12. INACTIVE INGREDIENTS (GENTLE MINT)
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL (FRESH MINT ORIGINAL)
    15. PRINCIPAL DISPLAY PANEL

Biotene Product Label

The following document was submitted to the FDA by the labeler of this product Glaxosmithkline Consumer Healthcare Holdings (us) Llc. 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(Fresh Mint Original)



Sodium monofluorophosphate (0.14% w/v fluoride ion)


Active Ingredient (Gentle Mint)



Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)


Purpose



Anticavity


Use



aids in the prevention of dental cavities.


Keep Out Of Reach Of Children 12 Years And Under.



If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. If symptoms of a dry mouth persist, consult a healthcare professional.


When Using This Product,



if irritation occurs discontinue use.


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



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


Directions (Fresh Mint Original)



Adults and children over 12 years

  • •apply toothpaste onto a soft bristle toothbrush
  • •brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

    • Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established.


Directions (Gentle Mint)



  • •adults and children 2 years of age and older:
    • oapply toothpaste onto a toothbrush
    • obrush teeth thoroughly, preferable after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimizing swallowing. Spit out after brushing.
    • oto minimize swallowing for children under 6 years of age, use a pea-sized amoun and supervise brushing and rinsing until good habits are established.
    • •children under 2 years of age: Consult a dentist or doctor.

Other Information



store at or below 25°C (77°F)


Inactive Ingredients (Fresh Mint Original)



Sorbitol, Glycerin, Calcium Pyrophosphate, Water, Hydrated Silica, Xylitol, Silica, Hydroxyethylcellulose, Isoceteth-20, Cellulose Gum, Flavor, Sodium Benzoate, Lactoperoxidase, Potassium Thiocyanate, glucose Oxidase, Lysozyme, Lactoferrin, Calcium Lactate. Contains milk and egg derivatives.


Inactive Ingredients (Gentle Mint)



sorbitol, hydrated silica, glycerin, calcium pyrophosphate, water, xylitol, silica, hydroxyethylcellulose, isoceteth-20, cellulose gum, flavor, sodium benzoate, calcium lactate.


Questions Or Comments?



Call toll-free 1-800-922-5856


Principal Display Panel (Fresh Mint Original)



NDC 0135-0487-01

biotene®

Protein-Enzyme System

DRY MOUTH

FLUORIDE TOOTHPASTE

Gentle, Low Foaming Formula

Formulated to Not Irritate a Dry Mouth

FRESH MINT ORIGINAL

NET WT 4.5 OZ (127.6g)

#1 RECOMMENDED DRY MOUTH BRAND

Helps Maintain Oral Environment

  • •Helps Prevent Cavities
  • •Formulated to Not Irritate a Dry Mouth
  • •Detergent Free (No SLS)
  • •Low Foaming, Mild Flavor
  • •Freshens Bad Breath

    • #1 Dentist & Hygienist Recommended Brand for Dry Mouth

    You may not realize you suffer from dry mouth symptoms until it causes dental problems. If you are experiencing some of the following problems, it may be due to a dry mouth.

    • •Constant dry feeling
    • •Sore or bleeding gums
    • •Cracked lips
    • •Bad breath
    • •Cavities

      • Dry mouth is commonly associated with the use of medications.

      Over 400 commonly used drugs may reduce your saliva flow.

      Biotene® Dry Mouth Toothpaste contains beneficial enzymes found in saliva and helps dry mouth sufferers maintain the oral environment and good oral hygiene.

      This product contains no saccharin.

      No sodium lauryl sulfate (SLS)

      BIOTENE and LP3 are trademarks of the GlaxoSmithKline group of companies.

      XYLITOL is a registered trademark of Danisco Sweetners Oy.

      www.biotene.com

      Naturally Sweetened with Xylitol®

      Distributed by:

      GlaxoSmithKline

      Consumer Healthcare, L.P.

      Moon Township, PA 15108

      ©2011 GlaxoSmithKline

      100939XA


Principal Display Panel



NDC 0135-0577-01

biotene®

Fluoride Toothpaste

#1 DENTIST RECOMMENDED DRY MOUTH BRAND

GENTLE MINT

GENTLE FORMULA

NET WT 4.3 OZ (121.9g)

#1 DENTIST RECOMMENDED DRY MOUTH BRAND

SPECIALLY FORMULATED TO NOT IRRITATE & HELPS MAINTAIN A HEALTHY ORAL ENVIRONMENT

  • •Helps freshen breath
  • •SLS free*
  • •Gentle formula
  • •Essential fluoride toothpaste protection

    • Also look for other biotene® products including biotene® Oral Rinse, biotene® Oralbalance® Gel and biotene® Mouth Spray

    *This product contains no Sodium Lauryl Sulfate (SLS)

    Trademarks are owned by or licensed to the GSK group of companies.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    ©2015 GSK group of companies or its licensor. All rights reserved.

    105172XB


* Please review the disclaimer below.