ABUTOL ANTISEPTIC WET WIPES CITRUS GARDEN- benzalkonium chloride cloth 
FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED 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 CITRUS GARDEN ANTISEPTIC WET WIPES

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

Warnings

For external use only

Do not use

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

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

Directions

Other information

Inactive ingredients

benzoic acid, citric acid, cocamidopropyl betaine, dehydroacetic acid, fragrance, glycerin, PEG-7 glyceryl cocoate, phenoxyethanol, polysorbate 20, propylene glycol, tetrasodium EDTA, water, 

PARIS
ANTISEPTIC AGENT

You may also report any serious side effects to

PO BOX 328, Wood Ridge, NJ 07075-328

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

untitled

Packaging

untitled

untitled

ABUTOL ANTISEPTIC WET WIPES  CITRUS GARDEN
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78850-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE SODIUM (UNII: MP1J8420LU)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78850-103-0120 in 1 PACKET08/28/2020
12.87 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/28/2020
Labeler - FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI (356117981)
Establishment
NameAddressID/FEIBusiness Operations
FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI356117981manufacture(78850-103)

Revised: 8/2020
Document Id: aba296df-477d-4f3b-b67b-ae5f20e40666
Set id: 78d8ce2f-4e95-49a2-9da9-74a60ebd2d46
Version: 1
Effective Time: 20200828
 
FULYA KOZMETIK ISLAK MENDIL IMALAT VE PAZARLAMA LIMITED SIRKETI