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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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 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

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.

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 Panel

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:71112-003-201 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 - Curaden AG (481145555)
Establishment
NameAddressID/FEIBusiness Operations
Trybol AG480305077manufacture(71112-003)

Revised: 7/2022
Document Id: e3a34951-384c-b46e-e053-2995a90a34fb
Set id: d35d70d9-6b7f-0542-e053-2995a90a9978
Version: 2
Effective Time: 20220712
 
Curaden AG