NDC | 65321-012-01, 65321-012-03 |
Set ID | 8e2ba8bf-2ba0-4f97-a0f4-844ecb4ef40f |
Category | HUMAN OTC DRUG LABEL |
Packager | Rubbermaid Commercial Products LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333 |
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
- Directions
- Inactive Ingredients
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 800mL Carton
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INGREDIENTS AND APPEARANCE
TC ENRICHEDFOAM ANTIBACTERIAL
triclosan soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65321-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Lactic Acid (UNII: 33X04XA5AT) Sodium Laureth-3 Sulfate (UNII: BPV390UAP0) Sodium Hydroxide (UNII: 55X04QC32I) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Benzyl Alcohol (UNII: LKG8494WBH) Methylchloroisothiazolinone (UNII: DEL7T5QRPN) Methylisothiazolinone (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65321-012-01 1 in 1 BOX 1 800 mL in 1 POUCH 2 NDC:65321-012-03 4 in 1 CARTON 2 1100 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 03/02/2010 Labeler - Rubbermaid Commercial Products LLC (049924368) Establishment Name Address ID/FEI Business Operations NWL Netherlands Production B.V. 489421698 ANALYSIS(65321-012) , MANUFACTURE(65321-012) , RELABEL(65321-012) , REPACK(65321-012)