LUVONE BODY WASH DAILY MOISTURIZING OATMEAL- benzalkonium chloride liquid 
INDUSTRIAS MC CLEAN S A S

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Luvone Body Wash Daily Moisturizing Oatmeal

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.

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

Other Information

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl betaine, Glycerin, Sodium laureth sulphate (and) Cocoamido MEA (and) Glycol Stearate (and) Gycol, Sodium Chloride, Lauramidopropylamine Oxide, Coco-Glucoside (and) Glyceryl Oleate, PEG-150 Distearate, Edetate Disodium, Citric Acid, Parfum, Avena sativa extract, DMDM Hydantoin and Iodopropynyl Butylcarbamate, CI 15510.

Package Labeling:

Bottle

LUVONE BODY WASH DAILY MOISTURIZING OATMEAL 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80683-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
COCO GLUCOSIDE (UNII: ICS790225B)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80683-002-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/2021
Labeler - INDUSTRIAS MC CLEAN S A S (886518381)

Revised: 7/2021
Document Id: c707094f-c5f6-da64-e053-2995a90a1ff2
Set id: c707094f-c5f5-da64-e053-2995a90a1ff2
Version: 1
Effective Time: 20210713
 
INDUSTRIAS MC CLEAN S A S