HANDCREAM ANTI-BACTERIAL- benzalkonium chloride cream

HANDCREAM ANTI-BACTERIAL by

Drug Labeling and Warnings

HANDCREAM ANTI-BACTERIAL by is a Otc medication manufactured, distributed, or labeled by Envisionary Life Health Science LLC, Natural Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.05%

Purpose

Antiseptic

Warnings

For external use only.

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away.

When using this product

• Avoid contact with eyes.
• If contact occurs, rinse eyes throughly with water.

Uses

to decrease bacteria on the skin.

Stop use and ask a doctor if

• irritation and redness develop.

Directions

• Apply on hands and rub in until fully absorbed.

OTHER SAFETY INFORMATION

• Store below 110 F (43 C)
• May discolor certain fabrics or surfaces.

Inactive ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HANDCREAM ANTI-BACTERIAL 
benzalkonium chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82416-0050
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 mL

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
ROSEMARY (UNII: IJ67X351P9)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PANTHENOL (UNII: WV9CM0O67Z)
GRAPEFRUIT (UNII: O82C39RR8C)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
UREA (UNII: 8W8T17847W)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 60 (UNII: CAL22UVI4M)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
PEG-100 STEARATE (UNII: YD01N1999R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SALICYLIC ACID (UNII: O414PZ4LPZ)
ARGININE (UNII: 94ZLA3W45F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OLIVE OIL (UNII: 6UYK2W1W1E)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
ALLANTOIN (UNII: 344S277G0Z)
CETYL ALCOHOL (UNII: 936JST6JCN)
MYRRH OIL (UNII: H74221J5J4)
LEMON OIL (UNII: I9GRO824LL)
MINERAL OIL (UNII: T5L8T28FGP)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ISOHEXADECANE (UNII: 918X1OUF1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82416-0050-2	1 in 1 BOX	11/24/2021
1		50 mL 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	part333A	11/24/2021

Labeler - Envisionary Life Health Science LLC (088049180)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Korea Co., Ltd.		688729438	manufacture(82416-0050)