Label: BEEPROPOLIS- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 58964-101-01 - Packager: Sinhwa Life Health Co Ltd
- 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 July 14, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions
Adults and children 6 years of age and older - Brush teeth thoroughly preferably after each meal or at least twice a day
or as directed by a dentist or doctor
Children under 12 years of age - To minimize swallowing, use a pea sized amount and supervise brushing
until good habits are established
Children under 5 years of age - Consult a dentist or doctor
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BEEPROPOLIS
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58964-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 100 mg in 100 g Inactive Ingredients Ingredient Name Strength PROPOLIS WAX (UNII: 6Y8XYV2NOF) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) STEVIOSIDE (UNII: 0YON5MXJ9P) XYLITOL (UNII: VCQ006KQ1E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) XANTHAN GUM (UNII: TTV12P4NEE) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) CITRUS PARADISI SEED (UNII: 12F08874Y7) PEPPERMINT OIL (UNII: AV092KU4JH) RACEMENTHOL (UNII: YS08XHA860) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58964-101-01 1 in 1 CARTON 1 180 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/01/2013 Labeler - Sinhwa Life Health Co Ltd (688492682) Establishment Name Address ID/FEI Business Operations Sinhwa Life Health Co Ltd 688492682 manufacture(58964-101)