Label: ANTIBACTERIAL BAR- triclosan soap
-
Contains inactivated NDC Code(s)
NDC Code(s): 40057-3000-1, 40057-3000-2, 40057-3000-3 - Packager: Charm-Tex, Inc
- 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 October 9, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- USES
- WARNINGS
- DIRECTIONS
- INACTIVE INGREDIENTS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1.4 gr Bar Soap Carton
-
INGREDIENTS AND APPEARANCE
ANTIBACTERIAL BAR
triclosan soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40057-3000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan 0.3 g in 100 g Inactive Ingredients Ingredient Name Strength Sodium Palmitate (UNII: JQ43KP6296) Sodium Cocoate (UNII: R1TQH25F4I) Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Sodium Chloride (UNII: 451W47IQ8X) Edetic Acid (UNII: 9G34HU7RV0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40057-3000-1 1000 in 1 CARTON 1 14.17 g in 1 PACKAGE 2 NDC:40057-3000-2 500 in 1 CARTON 2 42.52 g in 1 PACKAGE 3 NDC:40057-3000-3 144 in 1 CARTON 3 85 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 02/29/2012 Labeler - Charm-Tex, Inc (058347543)