NDC Code(s) : 63135-365-30
Packager : ESBA LABORATORIES INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NUMB ZONELIDOCAINE 5% GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63135-365
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE(UNII: 98PI200987)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)5 g in 100 g
ALOE VERA LEAF(UNII: ZY81Z83H0X)2 g in 100 g
BENZYL ALCOHOL(UNII: LKG8494WBH)0.8 g in 100 g
.ALPHA.-BISABOLOL, (+/-)-(UNII: 36HQN158VC)1 g in 100 g
EDETATE DISODIUM(UNII: 7FLD91C86K)0.025 g in 100 g
CARBOMER 940(UNII: 4Q93RCW27E)0.6 g in 100 g
GLYCERYL LAURATE(UNII: Y98611C087)2.5 g in 100 g
ALCOHOL(UNII: 3K9958V90M)36.75 g in 100 g
SHEA BUTTER(UNII: K49155WL9Y)2.5 g in 100 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63135-365-301 in 1 BOX 07/01/2015
130 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
OTC monograph final part346 07/01/2015

PRINCIPAL DISPLAY PANEL

Label on tube of Numb Zone 30 g

Numb Zone label

Outer carton of Numb Zone 30 g tube:

Numb Zone label