NDC Code(s) : 29784-191-01, 29784-191-02
Packager : Profoot, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ProClearz Tolnaftate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29784-191
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE(UNII: 06KB629TKV)
(TOLNAFTATE - UNII:06KB629TKV) 		TOLNAFTATE1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
DIMETHICONE(UNII: 92RU3N3Y1O)
DMDM HYDANTOIN(UNII: BYR0546TOW)
ELETTARIA CARDAMOMUM WHOLE(UNII: KH2S76267N)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
LAURETH-7(UNII: Z95S6G8201)
METHYLPARABEN(UNII: A2I8C7HI9T)
MINERAL OIL(UNII: T5L8T28FGP)
POLYACRYLAMIDE (1500 MW)(UNII: 5D6TC4BRWV)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:29784-191-021 in 1 BOX
1NDC:29784-191-0126 g in 1 APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 10/10/2012

PRINCIPAL DISPLAY PANEL

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