NDC Code(s) : 61543-6169-5
Packager : CCA Industries, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Scar Zone Burn Extra Strength Burn Relief Topical Analgesic and Antiseptic LIDOCAINE, BENZALKONIUM CHLORIDE GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61543-6169
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE(UNII: 98PI200987)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE2.00 g in 100 g
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
(BENZALKONIUM - UNII:7N6JUD5X6Y) 		BENZALKONIUM CHLORIDE0.13 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN(UNII: 344S277G0Z)
ONION(UNII: 492225Q21H)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
BENZYL ALCOHOL(UNII: LKG8494WBH)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
GLYCERIN(UNII: PDC6A3C0OX)
TEA TREE OIL(UNII: VIF565UC2G)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PHYTONADIONE(UNII: A034SE7857)
POLYSORBATE 60(UNII: CAL22UVI4M)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61543-6169-51 in 1 BOX
114 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 07/01/2010

PRINCIPAL DISPLAY PANEL


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