NDC Code(s) : 76058-102-01, 76058-102-02
Packager : Sungwon Pharmaceutical Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Apatite SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76058-102
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 MONOFLUOROPHOSPHATE1380 mg in 200 g
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
AMINOCAPROIC ACID(UNII: U6F3787206)
Spearmint oil(UNII: C3M81465G5)
Xylitol(UNII: VCQ006KQ1E)
Water(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
SORBITOL(UNII: 506T60A25R)
LEVOMENTHOL(UNII: BZ1R15MTK7)
Sodium Lauryl Sulfate(UNII: 368GB5141J)
METHYLPARABEN(UNII: A2I8C7HI9T)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
Sodium Chloride(UNII: 451W47IQ8X)
TRIBASIC CALCIUM PHOSPHATE(UNII: 91D9GV0Z28)
Titanium Dioxide(UNII: 15FIX9V2JP)
EUCALYPTUS OIL(UNII: 2R04ONI662)
Sodium Chloride(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76058-102-021 in 1 CARTON
1NDC:76058-102-01200 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 03/01/2011

PRINCIPAL DISPLAY PANEL

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