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| Product NDC Code | 0135-0557 | ||||||
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| Drug Name | Biotene fresh mint original |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | PASTE | ||||||
| RxCUI drug identifier | 416783, 1044547 |
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| Application Number | M022 | ||||||
| Labeler Name | Haleon US Holdings LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium Fluoride (0.15% w/v fluoride ion)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use aids in the prevention of dental cavities
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.BIOTENE Fresh Mint Original sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE XANTHAN GUM SACCHARIN SODIUM SUCRALOSE TITANIUM DIOXIDE SODIUM HYDROXIDE Fresh Mint BIOTENE Gentle Mint sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE XANTHAN GUM SACCHARIN SODIUM SUCRALOSE SODIUM HYDROXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 1 Gentle Mint
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel NDC 0135-0557-01 biotene ® FLUORIDE TOOTHPASTE GENTLE FORMULA SPECIALLY FORMULATED TO NOT IRRITATE FRESH MINT ORIGINAL NET WT 4.3 OZ (121.9g) FROM THE MAKERS OF BIOTENE #1 DENTIST & HYGIENTIST RECOMMENDED BRAND FOR DRY MOUTH SYMPTOMS HELPS MAINTAIN ORAL ENVIRONMENT • HELPS FRESHEN BAD BREATH • SLS FREE • BALANCED PH • GENTLE FORMULA • ESSENTIAL FLUORIDE TOOTH PROTECTION Also look for other biotene ® products including biotene ® Oral Rinses, biotene ® oralbalance Gel, and biotene ® Mouth Spray. ALWAYS FOLLOW THE LABEL This product contains no Sodium Lauryl Sulfate (SLS) Biotene, oralbalance and graphic elements are trademarks of the GSK group of companies. www.biotene.com Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2014 GSK 102875XC Biotene Fresh Mint Original 4.3 oz (121.9) carton
Principal Display Panel NDC 0135-0558-01 biotene ® FLUORIDE TOOTHPASTE GENTLE FORMULA SPECIALLY FORMULATED TO NOT IRRITATE GENTLE MINT NET WT 4.3 OZ (121.9g) FROM THE MAKERS OF BIOTENE #1 DENTIST & HYGIENTIST RECOMMENDED BRAND FOR DRY MOUTH SYMPTOMS HELPS MAINTAIN ORAL ENVIRONMENT • HELPS FRESHEN BAD BREATH • SLS FREE • BALANCED PH • GENTLE FORMULA • ESSENTIAL FLUORIDE TOOTH PROTECTION Also look for other biotene ® products including biotene ® Oral Rinses, biotene ® oralbalance Gel, and biotene ® Mouth Spray. ALWAYS FOLLOW THE LABEL This product contains no Sodium Lauryl Sulfate (SLS) Biotene, oralbalance and graphic elements are trademarks of the GSK group of companies. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2014 GSK 102874XC Biotene Gentle Mint Original 4.3 oz (121.9g) carton
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call toll-free 1-800-922-5856 weekdays
Storage and handling
Information about safe storage and handling of the drug product.Other information store below 25°C (77F°)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API