BEYOU ORANGE- toothpaste paste, dentifrice

BEYOU Orange by

Drug Labeling and Warnings

BEYOU Orange by is a Otc medication manufactured, distributed, or labeled by Curaden AG, Trybol AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

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

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.

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.

PRINCIPAL DISPLAY PANEL

Active Ingredients

Purpose

Use

Warning

OTC - Keep out of reach of children

Directions

Other Information

Inactive Ingredients

Dose and administration

Curaden

INGREDIENTS AND APPEARANCE

BEYOU ORANGE 
toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71112-003
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.095 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POTASSIUM THIOCYANATE (UNII: TM7213864A)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEACH (Peach + Apricot flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71112-003-20	1 in 1 BOX	12/17/2021
1		60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/17/2021

Labeler - Curaden AG (481145555)

Registrant - Curaden AG (481145555)

Establishment
Name	Address	ID/FEI	Business Operations
Trybol AG		480305077	manufacture(71112-003)