NDC Code(s) : 0395-6110-31, 0395-6110-58
Packager : Humco Holding Group, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lidocaine-Prilocaine-Cream BaseLidocaine-Prilocaine-Cream Base CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0395-6110
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE(UNII: 98PI200987)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE25 mg in 1 g
PRILOCAINE(UNII: 046O35D44R)
(PRILOCAINE - UNII:046O35D44R) 		PRILOCAINE25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
DIETHYLENE GLYCOL MONOPHENYL ETHER(UNII: LZU6ET206Z)
OCTYLDODECANOL(UNII: 461N1O614Y)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: O4446S9CRA)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDE(UNII: ZF29F7IK5I)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0395-6110-315800 g in 1 CONTAINER Type 0: Not a Combination Product
2NDC:0395-6110-5818000 g in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/20/2015

PRINCIPAL DISPLAY PANEL

NDC 0395-6110-31 5.8 kg

Lidocaine-Prilocaine-Cream Base
(lidocaine 2.5% and prilocaine 2.5%)
A " For Prescription Compounding Only" starburst label will be added to the container prior to distribution.
For Topical Use Only
Rx Only

Label 5.8 kg

PRINCIPAL DISPLAY PANEL

NDC 0395-6110-58 18 kg

Lidocaine-Prilocaine-Cream Base
(lidocaine 2.5% and prilocaine 2.5%)
A " For Prescription Compounding Only" starburst label will be added to the container prior to distribution.
For Topical Use Only

Rx Only

Label 19 kg

PRINCIPAL DISPLAY PANEL

The "For Prescription Compounding Only" starburst label will be added to the container prior to distribution.

Starburst Label