NDC Code(s) : 15455-1032-4
Packager : Alvix Laboratories,LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lidocaine HydrochlorideLidocaine Hydrochloride LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15455-1032
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS(UNII: EC2CNF7XFP)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE HYDROCHLORIDE ANHYDROUS3 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM SULFATE(UNII: 34S289N54E)
CALCIUM ACETATE(UNII: Y882YXF34X)
CETYL ALCOHOL(UNII: 936JST6JCN)
GLYCERIN(UNII: PDC6A3C0OX)
MINERAL OIL(UNII: T5L8T28FGP)
METHYLPARABEN(UNII: A2I8C7HI9T)
PETROLATUM(UNII: 4T6H12BN9U)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
STEARIC ACID(UNII: 4ELV7Z65AP)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:15455-1032-41 in 1 CARTON
1118 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/02/2015

PRINCIPAL DISPLAY PANEL

4 FL. OZ (118 mL) bottle

NDC 15455-1032-4

TOPICAL ANESTHETIC

LIDOCAINE
label
HCl 3% LOTION

Rx only

Net WT. 4 fl. oz. (118 mL)

4 FL. OZ (118 mL) carton

NDC 15455-1032-4

label

TOPICAL ANESTHETIC

LIDOCAINE

HCl 3% LOTION

Rx only

Net WT. 4 fl. oz. (118 mL)