ULTRACLEAN ANTIBACTERIAL HANDSOAP- benzalkonium chloride liquid 
ASILNUR KIMYA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI

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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Ultraclean® ANTIBACTERIAL HAND SOAP

Active Ingredient(s)  

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use(s)

For hand washing to help reduce bacteria and germs on the skin.

Warnings

For external use only.

Not edible, Don’t drink.

Prolonged skin contact may cause temporary irritation.

Do not Use

• in children less than 2 months of age.

• on open skin wounds.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Direction

• Pump into hands, wet as needed.

• Lather vigorously for at least 15 seconds.

• Wash hands, rinse thoroughly and dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 59-86ºF (15-30ºC). Avoid freezing and excessive heat above 104ºF (40ºC). May discolor certain fabrics and surfaces.

Inactive Ingredients

Aqua, Cocamidopropyl Betaine, Coco-Glucoside, Glycerin, Peg 150 Distearate, Cocomide MIPA,

Sodium Benzoate, Polyquaternium 7, Disodium EDTA, Lime Oil, Phenoxyethanol, Citric Acid,

Tocopheryl Acetate, Panthenol.

PLUS FORMULA PROTECTION

instant effect

Clean, Sanitize and Moisture

Free of paraben, dye and phthalates

ANTIBACTERIAL LIQUID SOAP

– Sanitizing formula to help reduce cross-contamination.

– Hands feel smooth, soft and refreshed.

Distributed by Civilon LLC

Clifton, NJ, 07011

MADE IN TURKEY

Packaging

IMAGE

ULTRACLEAN  ANTIBACTERIAL HANDSOAP
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80374-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO GLUCOSIDE (UNII: ICS790225B)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
LIME OIL (UNII: UZH29XGA8G)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PANTHENOL (UNII: WV9CM0O67Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80374-101-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/31/2020
Labeler - ASILNUR KIMYA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365642393)
Establishment
NameAddressID/FEIBusiness Operations
ASILNUR KIMYA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI365642393manufacture(80374-101)

Revised: 9/2020
Document Id: 0ec86f00-18c8-4d66-bcd1-84c33c8a98e9
Set id: cb1247f1-56fd-4263-9ccc-23d5ecc9523a
Version: 1
Effective Time: 20200901
 
ASILNUR KIMYA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI