Biotene
Sodium fluoride · Paste · Oral
Active ingredient
Active ingredient Sodium Fluoride (0.15% w/v fluoride ion)
Purpose
Purpose Anticavity
Uses
Use aids in the prevention of dental cavities
Warnings
Warnings Keep out of reach of children 12 years of age and under (Fresh Mint and Gentle Mint) If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Do not use if you are allergic to any of the ingredients. Keep out of reach of children 12 years of age and under. (PBF) 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. Do not use if you are allergic to any of the ingredients.
Keep out of reach of children
Keep out of reach of children 12 years of age and under (Fresh Mint and Gentle Mint) If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Do not use if you are allergic to any of the ingredients. Keep out of reach of children 12 years of age and under. (PBF) 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. Do not use if you are allergic to any of the ingredients.
Directions
Directions 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.
Other information
Other information store below 25°C (77F°)
Inactive ingredients
Inactive ingredients (Fresh Mint Original) Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide Inactive ingredients (Gentle Mint) Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Sodium Hydroxide, D&C Yellow #10, FD&C Blue #1
Questions?
Questions or comments? call toll-free 1-800-922-5856 weekdays
Label text from the FDA structured product label by Haleon US Holdings LLC (revised Nov 5, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sodium Fluoride in 2 products
- Sodium Monofluorophosphate in 1 product
Biotene NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0135-0557 | Sodium Fluoride 1.5 mg/g Paste | Haleon US Holdings LLC | OTC MONOGRAPH DRUG |
| 0135-0558 | Sodium Fluoride 1.5 mg/g Paste | Haleon US Holdings LLC | OTC MONOGRAPH DRUG |
| 0135-0577 | Sodium Monofluorophosphate 1.4 mg/g Paste | Haleon US Holdings LLC | OTC MONOGRAPH DRUG |
Biotene recalls
- D-1318-2015 Aug 19, 2015 · Class II · Terminated
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. - D-1319-2015 Aug 19, 2015 · Class II · Terminated
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Frequently asked questions
What is Biotene used for?
Use aids in the prevention of dental cavities
Who makes Biotene?
Biotene is listed by 1 labeler in the FDA NDC directory, including Haleon US Holdings LLC.
Has Biotene been recalled?
The FDA enforcement database lists 2 recalls for Biotene, most recently D-1318-2015 (class ii): Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.