Label: TRICLOSAN- antibacterial liquid soap refill soap
-
Contains inactivated NDC Code(s)
NDC Code(s): 50157-119-32 - Packager: Brands International
- 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 May 30, 2016
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)
- Drug Facts
- Purpose
- Uses
- WARNINGS
- Stop use and ask a doctor if
- When using this product
- Keep out of reach of children
- Directions
- Inactive Ingredients
- Package Label
-
INGREDIENTS AND APPEARANCE
TRICLOSAN
antibacterial liquid soap refill soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50157-119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 1.15 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM CHLORIDE (UNII: 451W47IQ8X) EDETIC ACID (UNII: 9G34HU7RV0) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) DMDM HYDANTOIN (UNII: BYR0546TOW) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50157-119-32 947 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/03/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/03/2016 Labeler - Brands International (243748238) Registrant - Sante Manufacturing Inc (252365486) Establishment Name Address ID/FEI Business Operations Brands International 243748238 manufacture(50157-119)