BEYOU Orange

Manufacturer
Curaden AG | Trybol AG
Effective date
2022-07-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:50:09

Label at a glance#

ProductBEYOU Orange
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Dosage and administration

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

Storage and handling

Do nont use if tamper proof seal is broken Store at room temperature.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.723%
(0.095% W/V fluoride ion)

Purpose

OTC - PURPOSE SECTION

Fluoride toothpaste

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Do nont use if tamper proof seal is broken

Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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 SECTION

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 Package Label Principal Display PanelPackage Label Principal Display Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71112-003-202024-01-30C16284748780-11030e365-1316-111a-e063-dadaa90a10e2d35d70d9-6b7f-0542-e053-2995a90a9978

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71112-003-20BEYOU Orange60 mL in 1 TUBEPASTE, DENTIFRICE602
71112-003-20BEYOU Orange1 in 1 BOXPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71112-003BEYOU ORANGE (TOOTHPASTE) PASTE, DENTIFRICE [CURADEN AG]2Legacy NDC, 2 package rows20220714_d35d70d9-6b7f-0542-e053-2995a90a9978.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71112-00371112-003-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e3a34951-384c-b46e-e053-2995a90a34fbd35d70d9-6b7f-0542-e053-2995a90a99782022-07-12WarningsExact identifier
spl id: e3a34951-384c-b46e-e053-2995a90a34fb
spl set id: d35d70d9-6b7f-0542-e053-2995a90a9978

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.