Biotene Paste
FDA Label NDC 0135-0577

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Biotene (NDC 0135-0577). 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 active ingredient(fresh mint original), active ingredient (gentle mint), purpose, use, keep out of reach of children 12 years and under., when using this product,, keep out of reach of children under 6 years of age., directions (fresh mint original), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.