NDC Code(s) : 76058-103-01, 76058-103-02
Packager : Sungwon Pharmaceutical Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dental guardian SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76058-103
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE(UNII: C810JCZ56Q)
(FLUORIDE ION - UNII:Q80VPU408O) 		SODIUM MONOFLUOROPHOSPHATE172 mg in 25 g
Inactive Ingredients
Ingredient Name Strength
LONICERA DASYSTYLA FLOWER BUD(UNII: J133K038DY)
BEE POLLEN(UNII: 3729L8MA2C)
PROPOLIS WAX(UNII: 6Y8XYV2NOF)
STEVIOL(UNII: 4741LYX6RT)
Xylitol(UNII: VCQ006KQ1E)
Aloe (UNII: V5VD430YW9)
ANGELICA ARCHANGELICA LEAF(UNII: 7RKK4V8HKA)
ACTAEA CIMICIFUGA ROOT(UNII: 65J267BAZT)
SORBITOL(UNII: 506T60A25R)
LEVOMENTHOL(UNII: BZ1R15MTK7)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
ANGELICA DAHURICA ROOT(UNII: 1V63N2S972)
ERYTHRITOL(UNII: RA96B954X6)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76058-103-021 in 1 CARTON
1NDC:76058-103-0125 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 06/02/2011

PRINCIPAL DISPLAY PANEL