LOLES- benzalkonium chloride cloth 
Diora Kimya Sanayi ve Ticaret 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.

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Antibacterial Hand Wipes for Personal Use

Active Ingredient(s)

Benzalkonium Chloride 0.115%

Purpose: Antibacterial

Purpose

Antibacterial, Hand Wipes

Use

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

Do not use

When using this product if eye contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor If irritation and redness develop and persist more than 72 hours.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Storage. Store at room temperature.

Dispensing. Lift lid and open seal band. Pull up center sheet and pull through the lid. Close lid to retain moisture.

Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping.

Disposal. Dispose of used wipes in trash receptacle after use. Do not flush.

Other information

Storage. Store at room temperature.

Please don't keep the package under direct sunlight or at high temperature.

Inactive ingredients

Water (Aqua), Propylene Glycol, Cocoamidopropyl Betaine, Glyceryl Cocoate, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Cetrimonium Chloride, Citric Acid, Fragrance (Perfum)

Package Label - Principal Display Panel

LOLES AB HAND WIPES 72 PCS

LOLES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73485-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.005 g
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.4 g
WATER (UNII: 059QF0KO0R) 98.662 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.28 g
BENZYL ALCOHOL (UNII: LKG8494WBH) 0.184 g
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) 0.05 g
EDETATE SODIUM (UNII: MP1J8420LU) 0.01 g
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 0.0075 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 0.0075 g
GLYCERYL COCOATE (UNII: WVK1CT5994) 0.186 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 0.093 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73485-003-0172 in 1 POUCH; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - Diora Kimya Sanayi ve Ticaret Limited Sirketi (533104358)
Registrant - US Naturals Corp (081035629)
Establishment
NameAddressID/FEIBusiness Operations
Diora Kimya Sanayi ve Ticaret Limited Sirketi533104358manufacture(73485-003)

Revised: 1/2022
Document Id: d6e47eb1-f49f-514e-e053-2995a90aa177
Set id: a845538f-e886-106a-e053-2a95a90a1406
Version: 3
Effective Time: 20220131
 
Diora Kimya Sanayi ve Ticaret Limited Sirketi