Label: SEGUCLEAN- benzalkonium chloride shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 79594-4000-1, 79594-4000-2, 79594-4000-3, 79594-4000-4 - Packager: Productos y Servicios de Limpieza Seguclean S.A. de C.V.
- 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 21, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- INDICATIONS AND USAGE
- DO NOT USE
- STOP USE
- PURPOSE
- KEEP OUT OF THE REACH OF CHILDREN.
- WARNINGS AND PRECAUTIONS
- WARNINGS
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
SEGUCLEAN
benzalkonium chloride shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79594-4000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.001 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.02 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.767 mL in 1 mL TRICLOSAN (UNII: 4NM5039Y5X) 0.001 mL in 1 mL ROSE OIL (UNII: WUB68Y35M7) 0.003 mL in 1 mL SODIUM LAURETH-5 SULFATE (UNII: 410Q7WN1BX) 0.2 mL in 1 mL DIETHANOLAMINE (UNII: AZE05TDV2V) 0.005 mL in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.003 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79594-4000-1 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2020 2 NDC:79594-4000-2 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2020 3 NDC:79594-4000-3 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2020 4 NDC:79594-4000-4 5000 mL in 1 BOTTLE; 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(79594-4000)
