Label: SEGUCLEAN- alcohol solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 79594-3000-1, 79594-3000-2, 79594-3000-3 - Packager: Productos y Servicios de Limpieza Seguclean S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
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 21, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS AND PRECAUTIONS
- WARNINGS
- PURPOSE
- INACTIVE INGREDIENTS
- PACKAGE LABEL
-
INGREDIENTS AND APPEARANCE
SEGUCLEAN
alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79594-3000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.015 mg in 1 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.2 mL in 1 mL Inactive Ingredients Ingredient Name Strength DIETHANOLAMINE (UNII: AZE05TDV2V) 0.003 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.763 mL in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.015 mL in 1 mL TRICLOSAN (UNII: 4NM5039Y5X) 0.001 mL in 1 mL ROSE OIL (UNII: WUB68Y35M7) 0.003 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79594-3000-1 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2020 2 NDC:79594-3000-2 5000 mL in 1 JUG; Type 0: Not a Combination Product 07/21/2020 3 NDC:79594-3000-3 20000 mL in 1 JUG; Type 0: Not a Combination Product 07/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/21/2020 Labeler - Productos y Servicios de Limpieza Seguclean S.A. de C.V. (951580477) Registrant - Productos y Servicios de Limpieza Seguclean S.A. de C.V. (951580477) Establishment Name Address ID/FEI Business Operations Productos y Servicios de Limpieza Seguclean S.A. de C.V. 951580477 manufacture(79594-3000)