Label: BEEPROPOLIS - sodium monofluorophosphate paste, dentifrice
- 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
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- INACTIVE INGREDIENT
Propolis extract, Vitamin E, Stevioside, Xylitol, Silicon Dioxide,
Carboxymethylcellulose sodium, Xanthan Gum, D-Sorbitol solution,
Polyethylene glycol 4000, Cocamidopropyl betaine, Grapefruit seed extract,
Peppermint Oil, DL-Menthol, WaterClose
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children under 6 years of age.Close
- INDICATIONS & USAGE
Uses - Aids in the prevention of cavitiesClose
- DOSAGE & ADMINISTRATION
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
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.
Do not Use if you are sensitive to bees or bee products.Close
- INGREDIENTS AND APPEARANCE
sodium monofluorophosphate paste, dentifrice
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58964-101 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 100 mg in 100 g Inactive Ingredients Ingredient Name Strength PROPOLIS WAX .ALPHA.-TOCOPHEROL STEVIOSIDE XYLITOL SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM XANTHAN GUM SORBITOL POLYETHYLENE GLYCOL 4000 COCAMIDOPROPYL BETAINE CITRUS PARADISI SEED PEPPERMINT OIL RACEMENTHOL WATER 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)