NDC Code(s) : 70372-729-01
Packager : CENTURA PHARMACEUTICALS INC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BLT 3TETRACAINE OINTMENT
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70372-729
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRACAINE(UNII: 0619F35CGV)
(TETRACAINE - UNII:0619F35CGV) 		TETRACAINE2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PEG-100 STEARATE(UNII: YD01N1999R)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
PEG-8 STEARATE(UNII: 2P9L47VI5E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70372-729-015 g in 1 POUCH Type 0: Not a Combination Product30/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 10/30/2016

LABELER - CENTURA PHARMACEUTICALS INC(084921637)

REGISTRANT - CENTURA PHARMACEUTICALS INC(084921637)

PRINCIPAL DISPLAY PANEL

BLT3