NDC Code(s) : 68747-6038-1
Packager : Dabur India Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Freshmint Premium AnticavitySODIUM FLUORIDE PASTE, DENTIFRICE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68747-6038
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 ION2.43 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL(UNII: 506T60A25R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
CARRAGEENAN(UNII: 5C69YCD2YJ)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE(UNII: B70850QPHR)
SACCHARIN SODIUM DIHYDRATE(UNII: SB8ZUX40TY)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM PYROPHOSPHATE(UNII: O352864B8Z)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68747-6038-124 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR 01/01/2013

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