PROBEE- propolis paste, dentifrice

Probee by

Drug Labeling and Warnings

Probee by is a Otc medication manufactured, distributed, or labeled by Seoul Propolis, Seoul Propolis Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

propolis

INACTIVE INGREDIENT

inactive ingredient: silica dioxide, sodium monofluorophosphate, sodium fluoride, sodium pyrophosphate, polyethylene glycol 1500, tocopherol acetate, sodium carboxymethyl cellulose, xylitol, hydrate sodium saccharine, green tea extract, menthol, green tea flavor, peppermint flavor, mint flavor, purified water

PURPOSE

for dental care use

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

brush your teeth by putting appropriate amount of tooth paste

WARNINGS

do not use other than oral cavity

DOSAGE & ADMINISTRATION

Make teeth strong. Clean and refresh oral cavity. Prevent dental cavities and bad breath.
Prevent from gingivitis, paradentitis, periodontal disease and gum disease and anti plaque.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROBEE 
propolis paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76254-1001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPOLIS WAX (UNII: 6Y8XYV2NOF) (PROPOLIS WAX - UNII:6Y8XYV2NOF)	PROPOLIS WAX	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
XYLITOL (UNII: VCQ006KQ1E)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MENTHOL (UNII: L7T10EIP3A)
PEPPERMINT (UNII: V95R5KMY2B)
MINT (UNII: FV98Z8GITP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76254-1001-1	50 g in 1 TUBE; Type 0: Not a Combination Product	12/28/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/10/2011

Labeler - Seoul Propolis (687390351)

Registrant - Seoul Propolis (687390351)

Establishment
Name	Address	ID/FEI	Business Operations
Seoul Propolis Co., Ltd.		687390351	manufacture(76254-1001)