Label: PROBEE- propolis paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 76254-1001-1 - Packager: Seoul Propolis
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 28, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROBEE
propolis paste, dentifriceProduct 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)