Biotene Paste
FDA Label NDC 0135-0577

11 label sections · Submitted to the FDA by Haleon Us Holdings Llc · 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, purpose, use, when using this product,, keep out of reach of children under 6 years of age., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities.

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

  • 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

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

Questions Or Comments?

Call toll-free 1-800-922-5856

Additional Information

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

@2019 GSK group of companies or its licensor.

Questions or Comments?

1-800-922-5856

Principal Display Panel

NDC 0135-0577-01

biotene®

Fluoride Toothpaste

SPECIALLY FORMULATED TO NOT IRRITATE

Helps prevent cavities & strengthen teeth

Gentle Formula

GENTLE MINT

NET WT 4.3 OZ (121.9g)

1000114 Front Carton

Biotene Gentle Mint Original 4.3 Oz (121.9g) (Image 01)

Biotene Gentle Mint Original 4.3 Oz (121.9g) (Image 01)

* Please review the disclaimer below.