LOLES- benzalkonium chloride soap
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 Bar Soap for Personal Use

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

Antimicrobial. Antibacterial Bar Soap.

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

For external use only.

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

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

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

Wet bar with water, wash skin and rinse

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)

AVENA

LOLES
benzalkonium chloride soap

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

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

Registrant - US Naturals Corp (081035629)

Name	Address	ID/FEI	Business Operations
Establishment
Diora Kimya Sanayi ve Ticaret Limited Sirketi		533104358	manufacture(73485-004)