Label: ULTRACLEAN ANTIBACTERIAL HANDSOAP- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 80374-101-50 - Packager: ASILNUR KIMYA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated September 1, 2020
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- SPL UNCLASSIFIED SECTION
- Active Ingredient(s)
- Purpose
- Use(s)
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Warnings
• For external use only.
• Not edible, Don’t drink.
• Prolonged skin contact may cause temporary irritation.
Do not Use
• in children less than 2 months of age.
• on open skin wounds.
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
ULTRACLEAN ANTIBACTERIAL HANDSOAP
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80374-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO GLUCOSIDE (UNII: ICS790225B) GLYCERIN (UNII: PDC6A3C0OX) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1) SODIUM BENZOATE (UNII: OJ245FE5EU) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) LIME OIL (UNII: UZH29XGA8G) PHENOXYETHANOL (UNII: HIE492ZZ3T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PANTHENOL (UNII: WV9CM0O67Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80374-101-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/31/2020 Labeler - ASILNUR KIMYA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365642393) Establishment Name Address ID/FEI Business Operations ASILNUR KIMYA KOZMETIK SANAYI VE TICARET ANONIM SIRKETI 365642393 manufacture(80374-101)
