NDC Code(s) : 61543-7254-3
Packager : CCA Industries, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Plus White Plus EVERY DAY WHITENINGSODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61543-7254
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE(UNII: C810JCZ56Q)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION1.14 g in 100 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL(UNII: 506T60A25R)
WATER(UNII: 059QF0KO0R)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
GLYCERIN(UNII: PDC6A3C0OX)
SODIUM POLYMETAPHOSPHATE(UNII: P1BM4ZH95L)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61543-7254-31 in 1 CARTON
1100 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 08/01/2013

PRINCIPAL DISPLAY PANEL

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