BEEPROPOLIS - sodium monofluorophosphate paste, dentifrice 
Sinhwa Life Health Co Ltd

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.

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Drug Facts

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 Type HUMAN OTC DRUG Item Code (Source) NDC:58964-101
Route of Administration ORAL DEA Schedule     
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)

Revised: 7/2013
Document Id: 6ee504e2-2477-4f12-89e5-77c500e52eb6
Set id: d6adca01-eb68-46e3-b988-654baf046a6e
Version: 3
Effective Time: 20130714
 
Sinhwa Life Health Co Ltd