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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BEYOU PeachSodium monofluorophosphate 0.723%

(0.095% w/v fluoride ion)

Fluoride toothpaste

Purpose

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

Box artwork

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 Artwork

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

Inactive

Aids in the prevention of dental cavities.

Use

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.

Using

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

Artwork

Do not use if tamper proof seal is broken

Store at room temperature.

Other

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

Dosage

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.

Warning

See image

artwork

BEYOU ORANGE 
toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71112-003
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.095 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POTASSIUM THIOCYANATE (UNII: TM7213864A)  
Product Characteristics
Color    Score    
ShapeSize
FlavorPEACH (Peach + Apricot flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71112-003-021 in 1 BOX12/17/2021
160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/17/2021
Labeler - Curaden AG (481145555)
Registrant - Trybol AG (480305077)
Establishment
NameAddressID/FEIBusiness Operations
Trybol AG480305077manufacture(71112-003)

Revised: 11/2022
Document Id: edd3aabf-561f-dde4-e053-2a95a90ae5c2
Set id: edd3aabf-561e-dde4-e053-2a95a90ae5c2
Version: 1
Effective Time: 20221119
 
Curaden AG