LOLES- benzalkonium chloride cloth

LOLES by

Drug Labeling and Warnings

LOLES by is a Otc medication manufactured, distributed, or labeled by Diora Kimya Sanayi ve Ticaret Limited Sirketi, US Naturals Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• In the eyes
• if you are allergic to any of the ingredients.

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

LOLES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73485-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.115 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73485-003-01	72 in 1 POUCH; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

Labeler - Diora Kimya Sanayi ve Ticaret Limited Sirketi (533104358)

Registrant - US Naturals Corp (081035629)

Establishment
Name	Address	ID/FEI	Business Operations
Diora Kimya Sanayi ve Ticaret Limited Sirketi		533104358	manufacture(73485-003)