ABUTOL ANTISEPTIC HAND WASH LEMON AND MINT- benzalkonium chloride liquid 
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.

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Abutol PARIS ANTISEPTIC HAND WASH Lemon & Mint

Drug Facts

Active ingredient

Benzalkonium chloride 0.12%

Purpose

Antiseptic

Uses

• for handwashing 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

• wet hands and forearms. Apply 5 millilitre (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 20 seconds

• rinse and repeat

• 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

Aqua, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, DMDM Hydantoin, FD&C Yellow No.5, Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA.

Abutol PARIS

with Moisturizer

Lemon & Mint - Cleans and soften hands

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

untitled

ABUTOL ANTISEPTIC HAND WASH LEMON AND MINT 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77418-207
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SULISOBENZONE (UNII: 1W6L629B4K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77418-207-20500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/30/2020
Labeler - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)
Establishment
NameAddressID/FEIBusiness Operations
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI566218248manufacture(77418-207)

Revised: 11/2020
Document Id: 223d022e-2172-4d9b-a474-aa1c527bf5ab
Set id: bb4d370f-5051-4957-a2f1-67aef7df1b1e
Version: 1
Effective Time: 20201103
 
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI