ANTISEPTIC LIQUID- benzalkonium chloride soap 
ITIMAT KOZMETIK URUNLERI 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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FONEX ANTISEPTIC LIQUID SOAP

Drug Facts

Active ingredient 

0,5% (w/w) Benzalkonium Chloride

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use

Warnings

For external use only

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if
• irritation and redness develop
• 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

• Squeeze a few pumps into your palms, foam with water and rinse.
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Deionised Water, Cocamidopropyl Betaine, Sodium Cocoamphoacetate, Lauryl Glucoside, Glycerin, PEG-150 Distearate, Hydrogenated Castor Oil,
Sodium Chloride, Citric Acid, CI 42090

Questions?

+1-646-301-0044
You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

Manufactured by: Itimat Kozmetik Urunleri San. Ve Tic. A.S.
Karadeniz District. M.Akif Avenue 1117/1 Street No:8
Gaziosmanpasa / ISTANBUL
COUNTRY OF ORIGIN: TURKEY
Batch No:

Expiry:

www.fonex.com.tr - info@fonex.com.tr

Packaging

image description

ANTISEPTIC LIQUID 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79392-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79392-102-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
2NDC:79392-102-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
3NDC:79392-102-03150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
4NDC:79392-102-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
5NDC:79392-102-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
6NDC:79392-102-06750 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
7NDC:79392-102-071000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
8NDC:79392-102-081500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
9NDC:79392-102-092000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
10NDC:79392-102-102500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
11NDC:79392-102-113000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
12NDC:79392-102-123500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
13NDC:79392-102-134000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
14NDC:79392-102-144500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
15NDC:79392-102-155000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
16NDC:79392-102-1610000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
17NDC:79392-102-1720000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
18NDC:79392-102-1836 in 1 BOX07/20/2020
1850 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/20/2020
Labeler - ITIMAT KOZMETIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (356579552)
Establishment
NameAddressID/FEIBusiness Operations
ITIMAT KOZMETIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI356579552manufacture(79392-102)

Revised: 7/2020
Document Id: 640b635e-3db4-4ba2-a813-371704737394
Set id: c384f8dd-cb56-4696-b869-5e7b1fd0019b
Version: 1
Effective Time: 20200720
 
ITIMAT KOZMETIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI