ULTRACLEAN ANTIBACTERIAL HANDSOAP- benzalkonium chloride liquid

ULTRACLEAN by

Drug Labeling and Warnings

ULTRACLEAN by is a Otc medication manufactured, distributed, or labeled by ASILNUR KIMYA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ULTRACLEAN  ANTIBACTERIAL HANDSOAP
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80374-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80374-101-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/31/2020

Labeler - ASILNUR KIMYA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365642393)

Establishment
Name	Address	ID/FEI	Business Operations
ASILNUR KIMYA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI		365642393	manufacture(80374-101)