Label: LOLES- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 73485-004-01 - Packager: Diora Kimya Sanayi ve Ticaret Limited Sirketi
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 1, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LOLES
benzalkonium chloride soapProduct 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)
