BEEPROPOLIS- sodium monofluorophosphate paste, dentifrice

BEEPROPOLIS by

Drug Labeling and Warnings

BEEPROPOLIS by is a Otc medication manufactured, distributed, or labeled by Sinhwa Life Health Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients

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, Water

ACTIVE INGREDIENT

Active Ingredients

Sodium monofluorophosphate

PURPOSE

Purpose

Anticaries

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses - Aids in the prevention of cavities

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

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.

Do not Use if you are sensitive to bees or bee products.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BEEPROPOLIS 
sodium monofluorophosphate paste, dentifrice

Product 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)