NDC Code(s) : 76058-106-01, 76058-106-02
Packager : Sungwon Pharmaceutical Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

APATITE PROFESSIONAL CALCIUM CARBONATE PASTE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76058-106
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
(CARBONATE ION - UNII:7UJQ5OPE7D) 		CALCIUM CARBONATE36.4 g in 130 g
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: O7TSZ97GEP)
ALCLOXA(UNII: 18B8O9DQA2)
Aminocaproic Acid(UNII: U6F3787206)
SORBITOL(UNII: 506T60A25R)
GLYCERIN(UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
Titanium dioxide(UNII: 15FIX9V2JP)
TRIBASIC CALCIUM PHOSPHATE(UNII: 91D9GV0Z28)
Xylitol(UNII: VCQ006KQ1E)
Stevioside(UNII: 0YON5MXJ9P)
LEVOMENTHOL(UNII: BZ1R15MTK7)
Peppermint oil(UNII: AV092KU4JH)
Eucalyptus oil(UNII: 2R04ONI662)
Sodium Lauryl Sulfate(UNII: 368GB5141J)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76058-106-021 in 1 CARTON
1NDC:76058-106-01130 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/14/2013

PRINCIPAL DISPLAY PANEL

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