Label: ANTISEPTIC LIQUID- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 79392-102-01, 79392-102-02, 79392-102-03, 79392-102-04, view more79392-102-05, 79392-102-06, 79392-102-07, 79392-102-08, 79392-102-09, 79392-102-10, 79392-102-11, 79392-102-12, 79392-102-13, 79392-102-14, 79392-102-15, 79392-102-16, 79392-102-17, 79392-102-18 - Packager: ITIMAT KOZMETIK URUNLERI SANAYI VE TICARET ANONIM 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 July 20, 2020
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- Drug Facts
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- Inactive ingredients
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- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
ANTISEPTIC LIQUID
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79392-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) GLYCERIN (UNII: PDC6A3C0OX) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79392-102-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 2 NDC:79392-102-02 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 3 NDC:79392-102-03 150 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 4 NDC:79392-102-04 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 5 NDC:79392-102-05 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 6 NDC:79392-102-06 750 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 7 NDC:79392-102-07 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 8 NDC:79392-102-08 1500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 9 NDC:79392-102-09 2000 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 10 NDC:79392-102-10 2500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 11 NDC:79392-102-11 3000 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 12 NDC:79392-102-12 3500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 13 NDC:79392-102-13 4000 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 14 NDC:79392-102-14 4500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 15 NDC:79392-102-15 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 16 NDC:79392-102-16 10000 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 17 NDC:79392-102-17 20000 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2020 18 NDC:79392-102-18 36 in 1 BOX 07/20/2020 18 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/20/2020 Labeler - ITIMAT KOZMETIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (356579552) Establishment Name Address ID/FEI Business Operations ITIMAT KOZMETIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 356579552 manufacture(79392-102)