UltracleanTM ANTIBACTERIAL HAND SOAP

ULTRACLEAN ANTIBACTERIAL HANDSOAP by

Drug Labeling and Warnings

ULTRACLEAN ANTIBACTERIAL HANDSOAP by is a Otc medication manufactured, distributed, or labeled by Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTRACLEAN ANTIBACTERIAL HANDSOAP- benzalkonium chloride soap 
Endeks Kimya 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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UltracleanTM ANTIBACTERIAL HAND SOAP

Drug Facts

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.

Directions

• 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 59-86°F (15-30°C). Avoid freezing and excessive heat above 104°F (40C). May discolor certain fabrics and surfaces.

Inactive ingredients

Aqua, Cocamidopropyl Betaine, Coco Glucoside, Glycerin, Peg-150 Distearate, Cocamide MIPA, Sodium Chloride, Polyquaternium-7, Disodium EDTA, Lavender Extract, Phenoxyethanol, Ethyhexylglycerin, Tocopheryl Acetate, Panthenol.

PLUS

FORMULA

PROTECTION

instant effect!

Clean, Sanitize and Moisture

Free of Paraben, Dye and Phthalates

-Sanitizing formula to help reduce cross-contamination.

-Hands feel smooth, soft and refreshed.

Distributed by

Civilon LLC

Clifton, NJ, 07011

MADE IN TURKEY

Packaging

ULTRACLEAN ANTIBACTERIAL HANDSOAP 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78089-028
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 CHLORIDE (UNII: 451W47IQ8X)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78089-028-01	1 in 1 CARTON	07/20/2020	05/01/2021
1		500 mL in 1 BOTTLE, PLASTIC; 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	part333E	07/20/2020	05/01/2021

Labeler - Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi (565678914)

Establishment
Name	Address	ID/FEI	Business Operations
Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi		565678914	manufacture(78089-028)

Revised: 7/2021

Document Id: 914f73e8-7132-44fd-8c26-8b074d8e3f61

34390-5

Set id: ae0e0a8d-2772-4404-83f8-0940932bcdd0

Version: 2

Effective Time: 20210706

 

Endek