ABUTOL SANITIZING LEMON AND MINT- benzalkonium chloride spray 
ATAK FARMA KOZMETIK VE KIMYA SANAYI 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.

----------

Abutol PARIS Sanitizing Spray Lemon & Mint

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

• Hand sanitizer to decrease bacteria on the skin
• Recommended for repeated use
• For use when soap and water are not available

Warnings

For external use only. Protect from the sunlight.

Do not use
• on children less than 2 months of age
• on open skin wounds

When using this product • Avoid use on/or around eyes, ears, mouth, broken/ irritated skin or large areas of body. In case of a contact with eyes, rinse thoroughly with water several minutes. do not inhale or ingest

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

Directions

• Hold upright at 6-7 inches away from surface and spray evenly. Repeat application a necessary when using this product to avoid swallowing

Other information

• store between 15-30 C (59-86F)

Inactive ingredients

Aqua, FD&C Blue No.1, FD&C Red No.40, Glycerin, Parfum.

Kills 99.99% of Germs *

* KILLS 99.9 OF MOST COMMON GERMS, BACTERIA AND VIRUSES.

Distributed by:
American Brands and More LLC,
Wood Ridge, NJ 07075

Made in TURKEY
You may also report any serious side effects to
PO Box 328, Wood Ridge, NJ 07075-328

Packaging

IMAGE

ABUTOL SANITIZING LEMON AND MINT 
benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77418-802
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77418-802-101000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/06/2020
Labeler - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)
Establishment
NameAddressID/FEIBusiness Operations
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI566218248manufacture(77418-802)

Revised: 11/2020
Document Id: d2b6dc38-b1da-46c4-87ee-f4720b290a9d
Set id: 61e13f9e-ce85-4035-95cf-41493956d021
Version: 1
Effective Time: 20201105
 
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI