LOLES- benzalkonium chloride soap

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 Bar Soap for Personal Use

ACTIVE INGREDIENT

Benzalkonium Chloride........0.10%

PURPOSE

Antimicrobial. Antibacterial Bar Soap.

INDICATIONS & USAGE

• For washing to decrease bacteria on the skin
• Recommended for repeated use

WARNINGS

For external use only.

WHEN USING

When using this product, do not use in or near the eyes. If contact occurs, rinse thorougly with water.

STOP USE

Stop use and ask doctor if irritation or rash appears and lasts.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

• Wet bar with water, wash skin and rinse

INACTIVE INGREDIENT

Sodium Palmate, Sodium Palm Kernelate, Aqua (Water), Fragrance (Parfum), Glycerin, Palm Acid, Sodium Chloride, Tetrasodium EDTA, Tetrasodium Etidronate, Avena Sativa (Oat) Kernel Flour, Tocopheryl Acetate (Vitamin E)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOLES 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73485-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.02 g  in 100 g
SODIUM PALMATE (UNII: S0A6004K3Z)	65 g  in 100 g
WATER (UNII: 059QF0KO0R)	15 g  in 100 g
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)	16 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	1.5 g  in 100 g
EDETATE SODIUM (UNII: MP1J8420LU)	0.02 g  in 100 g
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.48 g  in 100 g
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)	0.02 g  in 100 g
FRAGRANCE 13576 (UNII: 5EM498GW35)	0.86 g  in 100 g
PALM ACID (UNII: B6G0Y5Z616)	0.5 g  in 100 g
AVENA SATIVA LEAF (UNII: 206PI19V7R)	0.5 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73485-004-01	200 g in 1 BOX; Type 0: Not a Combination Product	12/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/01/2022

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(73485-004)