Your browser does not support JavaScript! BEEPROPOLIS (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SINHWA LIFE HEALTH CO LTD]
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BEEPROPOLIS (sodium monofluorophosphate) paste, dentifrice
[Sinhwa Life Health Co Ltd]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

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 Ingredients

Sodium monofluorophosphate

Purpose

Anticaries

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

Uses - Aids in the prevention of cavities

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

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.

copy of label

BEEPROPOLIS 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58964-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION100 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58964-101-011 in 1 CARTON
1180 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/01/2013
Labeler - Sinhwa Life Health Co Ltd (688492682)
Establishment
NameAddressID/FEIBusiness Operations
Sinhwa Life Health Co Ltd688492682manufacture(58964-101)

Revised: 7/2013
 
Sinhwa Life Health Co Ltd

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