NDC Code(s) : 60931-303-01
Packager : Yangzhou Holyshine Industrial Co. Ltd

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amerfresh FluorideSODIUM FLUORIDE PASTE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60931-303
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION2.2 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL(UNII: 506T60A25R)
WATER(UNII: 059QF0KO0R)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
METHYLPARABEN SODIUM(UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM(UNII: 625NNB0G9N)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60931-303-017.1 g in 1 PACKET Type 0: Not a Combination Product10/12/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 10/12/2016

PRINCIPAL DISPLAY PANEL

LabelLabel