ULTRACLEAN X ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

ULTRACLEAN X by

Drug Labeling and Warnings

ULTRACLEAN X by is a Otc medication manufactured, distributed, or labeled by BOSS KOZMETIK VE DIS TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

Hand sanitizer wipes to help reduce bacteria and germs on the skin. Recommended for repeated use.

Warnings

For external use only

When using this product avoid contacting with eyes.

In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition 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

Take wipe and rub thoroughly over all of both hands, Wet hands thoroughly with wipe and allow to dry, discard after use.

Children under 6 years of age should be supervised when using this product.

Other information

Store at room temperature. Keep tightly closed when not use. Dispose of used wipe in trash. Do not flush.

INACTIVE INGREDIENT

Inactive Ingredients: Aqua (Water),  Benzoic Acid, Dehydroacetic Acid, Dicaprylyl Carbonate, Glycerin, Lauryl Glucoside, Lime Oil, Phenoxyethanol, Polyglyceryl-2 Dipolyhydroxystearate

SPL UNCLASSIFIED SECTION

PLUS FORMULA PROTECTION

instant effect!

Free of Paraben, Dye and Phthalates

SANITIZER

ANTIBACTERIAL WET WIPES

FOR HAND SANITIZING TO DECREASE BACTERIA AND GERMS ON THE SKIN

Sanitizing formula to help reduce cross-contamination and risk of infection.

Leaves no stickiness or residue on hands.

 Hands feel smooth, soft and refreshed.

To Open Package:

Flip open dispensing lid 

Locate wipe at center of roll and thread through small opening in lid

For best results dispense wipes at an angle 

Always close lid securely between uses to retain moisture

TO DISPOSE WIPE: Place in a waste basket after use.

DO NOT FLUSH

Distributed by

Civilon LLC

Clifton, NJ, 07011

MADE IN TURKEY

OZONE FRIENDLY

Packaging

INGREDIENTS AND APPEARANCE

ULTRACLEAN X  ANTIBACTERIAL WET WIPES
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80445-101
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)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
LIME OIL (UNII: UZH29XGA8G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80445-101-72	72 in 1 CANISTER	08/31/2020
1		4 mL in 1 PACKAGE; 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	part333A	08/31/2020

Labeler - BOSS KOZMETIK VE DIS TICARET ANONIM SIRKETI (504479258)

Establishment
Name	Address	ID/FEI	Business Operations
BOSS KOZMETIK VE DIS TICARET ANONIM SIRKETI		504479258	manufacture(80445-101)