NDC Code(s) : 43269-634-01
Packager : SJ Creations, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Antibacterial Hand Mistletoe and Mint BENZALKONIUM CHLORIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43269-634
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
(BENZALKONIUM - UNII:7N6JUD5X6Y) 		BENZALKONIUM CHLORIDE.13 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
MINERAL OIL(UNII: T5L8T28FGP)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
DMDM HYDANTOIN(UNII: BYR0546TOW)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SULISOBENZONE(UNII: 1W6L629B4K)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)(UNII: 0L414VCS5Y)
POLYSORBATE 60(UNII: CAL22UVI4M)
DIMETHICONE(UNII: 92RU3N3Y1O)
STARCH, WHEAT(UNII: 79QS2MG2LP)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
PANTHENOL(UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE, D-(UNII: A7E6112E4N)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43269-634-0129 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 09/03/2010

PRINCIPAL DISPLAY PANEL

image of sj10214mtlotiontubewrap