NDC Code(s) : 70036-010-30, 70036-010-05
Packager : Cloverleaf Pharma LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LIDO-RX Lidcaine 4.0% Capsaicin 0.10% CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70036-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE(UNII: 98PI200987)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE4 g in 30 g
CAPSAICIN(UNII: S07O44R1ZM)
(CAPSAICIN - UNII:S07O44R1ZM) 		CAPSAICIN0.10 g in 30 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
MYRISTYL MYRISTATE(UNII: 4042ZC00DY)
GLYCERIN(UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
LANOLIN OIL(UNII: OVV5IIJ58F)
STEARIC ACID(UNII: 4ELV7Z65AP)
METHYLPARABEN(UNII: A2I8C7HI9T)
DIAZOLIDINYL UREA(UNII: H5RIZ3MPW4)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
DISODIUM EDTA-COPPER(UNII: 6V475AX06U)
ALLANTOIN(UNII: 344S277G0Z)
TRIETHANOLAMINE LACTATE(UNII: 064C51N81O)
POLYSORBATE 60(UNII: CAL22UVI4M)
DIMETHICONE(UNII: 92RU3N3Y1O)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
VITAMIN A(UNII: 81G40H8B0T)
VITAMIN D(UNII: 9VU1KI44GP)
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70036-010-3030 g in 1 TUBE Type 0: Not a Combination Product
2NDC:70036-010-055 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/25/2016

PRINCIPAL DISPLAY PANEL

  

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