BEYOU Orange

Manufacturer
Curaden AG | Trybol AG
Effective date
2022-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:47:13

Label at a glance#

ProductBEYOU Orange
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure12 sections

Boxed warning

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.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

BEYOU PeachBEYOU PeachSodium monofluorophosphate 0.723%

(0.095% w/v fluoride ion)

OTC - PURPOSE SECTION

Fluoride toothpaste

PurposePurpose

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

Box artworkBox artwork

BOXED WARNING 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.

Box ArtworkBox Artwork

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Hydrated silica, Sorbitol, Xylitol, Panthenol, Aroma, Xanthan gum, cocamidropropyl betaine, Microcrystalline cellulose, Decyl glucoside, Hydroxyapatite (nano), Glucose oxidase, Mannitol, Malodextrin, 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-methol, Centella asiatica extract, Citrus aurantium amara fruit extract, Potassium thiocyanate, Polylysine, Cetyl alcohol, Linalool, Silica, Potassium chloride, Tin oxide, Harpagophytum procumbens root extract, CI 77491, CI 77492

InactiveInactive

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

UseUse

OTC - WHEN USING SECTION

Adults and children 2 years of age and older - Brush teeth thoroughly, preferanly after each meal or at least twice a day, or as directed by a dentist or doctor.

Children under 6 years of age - Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

UsingUsing

OTC - ASK DOCTOR SECTION

Children under 6 years of age - Consult dentist or doctor.

ArtworkArtwork

OTHER SAFETY INFORMATION

Do not use if tamper proof seal is broken

Store at room temperature.

OtherOther

DOSAGE & ADMINISTRATION SECTION

Don't forget: A pea-size amount of toothpaste is enough.

DosageDosage

WARNINGS SECTION

Keep out of reach of children under 6 years of age. If motr than used for brushing is accidentally swallowed, get medical help or contact Poison Control Center right away.

WarningWarning

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See image

artworkartwork

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71112-003-022024-01-30C16284748780-11030e364-fed3-111a-e063-dadaa90a10e2edd3aabf-561e-dde4-e053-2a95a90ae5c2

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
71112-00371112-003-02

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
edd3aabf-561f-dde4-e053-2a95a90ae5c2edd3aabf-561e-dde4-e053-2a95a90ae5c22022-11-19Boxed warning, WarningsExact identifier
spl id: edd3aabf-561f-dde4-e053-2a95a90ae5c2
spl set id: edd3aabf-561e-dde4-e053-2a95a90ae5c2

Reported adverse events (FAERS/openFDA)#

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