Label: PRO ADVANTAGE ANTIBACTERIAL- triclosan liquid
- NDC Code(s): 43128-128-03
- Packager: NDC National Distribution & Contracting, 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 March 15, 2023
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- Pro Advantage Antibacterial Liquid Soap
- Active Ingredient
- Purpose
- Use
- Warnings
- Directions
- Inactive Ingredients
- REF: P778128 NDC 43128-108-03
- Product Label
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INGREDIENTS AND APPEARANCE
PRO ADVANTAGE ANTIBACTERIAL
triclosan liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43128-128 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 3 mg in 0.001 L Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) COCAMINE OXIDE (UNII: QWA2IZI6FI) SODIUM CHLORIDE (UNII: 451W47IQ8X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43128-128-03 3.8 L in 1 JUG; Type 0: Not a Combination Product 04/24/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/24/2013 Labeler - NDC National Distribution & Contracting, Inc. (009831413) Establishment Name Address ID/FEI Business Operations Dukal 088520668 manufacture(43128-128)