BEYOU Orange by Curaden AG / Trybol AG

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]

BEYOU ORANGE- toothpaste paste, dentifrice 
Curaden AG

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sodium monofluorophosphate 0.723%

(0.095% w/v fluoride ion)

Fluoride toothpaste

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

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.

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

Aids in the prevention of dental cavities.

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.

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

Do not use if tamper proof seal is broken

Store at room temperature.

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

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.

See image

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)	Â
POTASSIUM THIOCYANATE (UNII: TM7213864A)	Â

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71112-003-02	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 - Trybol AG (480305077)

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

Revised: 11/2022

Document Id: edd3aabf-561f-dde4-e053-2a95a90ae5c2

34390-5

Set id: edd3aabf-561e-dde4-e053-2a95a90ae5c2

Version: 1

Effective Time: 20221119

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