Label: BEYOU ORANGE- toothpaste paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 71112-003-02 - Packager: Curaden AG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 19, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- BOXED WARNING (What is this?)
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INACTIVE INGREDIENT
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
- INDICATIONS & USAGE
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WHEN USING
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.
- ASK DOCTOR
- OTHER SAFETY INFORMATION
- DOSAGE & ADMINISTRATION
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BEYOU ORANGE
toothpaste paste, dentifriceProduct 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:71112-003-02 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)
