OMEDI ANTI-BACTERIAL HAND CREAM- benzalkonium chloride cream

OMEDI Anti-bacterial hand cream by

Drug Labeling and Warnings

OMEDI Anti-bacterial hand cream by is a Otc medication manufactured, distributed, or labeled by Natural Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OMEDI ANTI-BACTERIAL HAND CREAM 
benzalkonium chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74646-3050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.025 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALLANTOIN (UNII: 344S277G0Z)
ISOHEXADECANE (UNII: 918X1OUF1E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
UREA (UNII: 8W8T17847W)
YELLOW WAX (UNII: 2ZA36H0S2V)
MINERAL OIL (UNII: T5L8T28FGP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SHEA BUTTER (UNII: K49155WL9Y)
SALICYLIC ACID (UNII: O414PZ4LPZ)
ARGININE (UNII: 94ZLA3W45F)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GRAPEFRUIT (UNII: O82C39RR8C)
ROSEMARY (UNII: IJ67X351P9)
PEG-100 STEARATE (UNII: YD01N1999R)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74646-3050-2	1 in 1 BOX	05/29/2020
1	NDC: 74646-3050-1	50 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 not final	part333E	05/29/2020

Labeler - Natural Korea Co., Ltd. (688729438)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Korea Co., Ltd.		688729438	manufacture(74646-3050)