NDC Code(s) : 15455-9526-1
Packager : Alvix Laboratories, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CidalEazeLidocaine Hydrochloride CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15455-9526
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE(UNII: V13007Z41A)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE30 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM SULFATE(UNII: 34S289N54E)
CETYL ALCOHOL(UNII: 936JST6JCN)
CALCIUM ACETATE(UNII: Y882YXF34X)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
METHYLPARABEN(UNII: A2I8C7HI9T)
MINERAL OIL(UNII: T5L8T28FGP)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
STEARIC ACID(UNII: 4ELV7Z65AP)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
PETROLATUM(UNII: 4T6H12BN9U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:15455-9526-1453.6 g in 1 JAR Type 0: Not a Combination Product08/11/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/11/2015 09/30/2018

PRINCIPAL DISPLAY PANEL

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Topical Anesthetic / Rx Only

CidalEaze (Lidocaine 3% Cream)

Label