Active Ingredient(S)
Sodium monofluorophosphate 0.723%
(0.095% W/V fluoride ion)
Beyou Orange
FDA Label NDC 71112-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Curaden Ag for the product Beyou Orange (NDC 71112-003). 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(s), purpose, use, warnings, otc - keep out of reach of children, 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
Purpose
Fluoride toothpaste
Use
Aids in the prevention of dental cavities.
Warnings
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 2 years of age and older: Brush teeth thoroughly, preferably afler each meal or at least twice a day, or as directed by a dentist or doctor
Children under 6 years of age: Instructin good brushing and rising habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision
Children under 6 years of age: Consult dentist or doctor
Other Information
Do nont use if tamper proof seal is broken
Store at room temperature.
Inactive Ingredients
AQUA, GLYCERIN, HYDRATED SILICA, SORBITOL, XYLITOL, PANTHENOL, AROMA, XANTHAN GUM, COCAMIDOPROPYL BETAINE, MICROCRYSTALLINE CELlLn.OSE, DECYL GLUCOSIDE, HYDROXYAPATITE (NANO), GLUCOSE OXIDASE, MANNITOL. MALTODEXTRIN, MICA, SUCRALOSE, CITRIC ACID, SODIUM HYDROXIDE, ZEA MAYS STARCH, ECHINACEA PURPUREA ROOT EXTRACT, TITANIUM DIOXIDE, SODIUM CHLORIDE, D-LIMONENE, SODIUM METABISULFITE, GLUCOSE, CALCIUM CARBONATE, L-MENTHOL, CENTELLAASIATICAEXTRACT, CITRUSAURANTIUM AMARA FRUIT EXTRACT, POTASSIUM THIOCYANATE, POLYLYSINE, CETYL ALCOHOL, LINALOOL, SILICA, POTASSIUM CHLORIDE, TIN OXIDE, HARPAGOPHYTI.JM PROCUMBENS ROOT EXTRACT,
Cl77492,CITT491
Dosage & Administration
A pea-sized amount of toothpaste is enough. For the best whitening results: Do not rinse your mouth afterwards. Be gentle when brushing and use a toothbrush with soft, high-density bristles. Once a day, brush between your teeth with an interdental brush to keep your gums and teeth healthier, and your breath fresher.
Package Label.Principal Display Panel
Active Ingredients
Purpose
Use
Warning
OTC - Keep out of reach of children
Directions
Other Information
Inactive Ingredients
Dose and administration
Curaden
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