NDC Code(s) : 70372-727-01
Packager : CENTURA PHARMACEUTICALS INC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BLT 1BENZOCAINE OINTMENT
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70372-727
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE(UNII: U3RSY48JW5)
(BENZOCAINE - UNII:U3RSY48JW5) 		BENZOCAINE20 g in 100 g
Inactive Ingredients
Ingredient Name Strength
PEG-100 STEARATE(UNII: YD01N1999R)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
CETEARYL OLIVATE(UNII: 58B69Q84JO)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
PEG-8 STEARATE(UNII: 2P9L47VI5E)
PETROLATUM(UNII: 4T6H12BN9U)
SORBITAN OLIVATE(UNII: MDL271E3GR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70372-727-015 g in 1 POUCH Type 0: Not a Combination Product15/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 10/15/2016

LABELER - CENTURA PHARMACEUTICALS INC(084921637)

REGISTRANT - CENTURA PHARMACEUTICALS INC(084921637)

PRINCIPAL DISPLAY PANEL

BLT 1