NDC Code(s) : 70411-101-50
Packager : H2Ocean, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NothingBenzalkonium chloride, Lidocaine LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70411-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
(BENZALKONIUM - UNII:7N6JUD5X6Y) 		BENZALKONIUM CHLORIDE0.13 g in 100 mL
LIDOCAINE HYDROCHLORIDE ANHYDROUS(UNII: EC2CNF7XFP)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
POLOXAMER 124(UNII: 1S66E28KXA)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
DISODIUM ETHYLENEDIAMINEDIACETATE(UNII: EQL53S5L0F)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70411-101-5050 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product15/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 02/15/2016

PRINCIPAL DISPLAY PANEL

H2Ocean

First in First Aid(TM)

NOTHING

Pain Relieving Foam Soap with Lidocaine

antibacterial anesthetic

1.7 fl. oz. (50 mL)

20160215 101 Benzalk Chl Lido Nothing