LUVONE HAND ANTIBACTERIAL ROSES- benzalkonium chloride liquid

Luvone Hand antibacterial Roses by

Drug Labeling and Warnings

Luvone Hand antibacterial Roses by is a Otc medication manufactured, distributed, or labeled by INDUSTRIAS MC CLEAN S A S. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Benzalkonium Chlorie 0.13%

Purpose

Antibacterial

Use(S)

For hand washing to decrease bacteria on the skin.

Warning(S)

For external use only. Hands only.

Do not use

• In children less than 2 months of age.
• On open skin wounds.

When using this product

Avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if

irritation or redness develops. Conditions persists for more than 72 hours.

Keep out of reach of children.

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

Directions

• Pum into hands, wet as nedeed.
• Lather vigorously for at least 15 seconds
• Wash skin, rinse thoroughly and dry.

Other Information

• Store at room temperature, in a cool and dry place.

Inactive Ingredients

Aqua, Cetrimonium Choride, Glycerin, Lauramidopropylamine Oxide, Cocamidopropyl betaine, Cocoamido MEA, Coco-Glucoside (and) Glyceryl Oleate, PEG-150 Distearate, Citric Acid, edetate disodium, Parfum, CI 17200.

Package Labeling:

INGREDIENTS AND APPEARANCE

LUVONE HAND ANTIBACTERIAL ROSES 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80683-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERYL OLEATE (UNII: 4PC054V79P)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80683-005-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2021

Labeler - INDUSTRIAS MC CLEAN S A S (886518381)