Label: ULTRA DISH- chloroxylenol 0.30% liquid
- NDC Code(s): 46994-568-50
- Packager: Save A Lot
- 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 May 11, 2022
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INGREDIENTS AND APPEARANCE
ULTRA DISH
chloroxylenol 0.30% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46994-568 Route of Administration topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3.06 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALCOHOL (UNII: 3K9958V90M) PHENOXYETHANOL (UNII: HIE492ZZ3T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) EDETATE SODIUM (UNII: MP1J8420LU) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46994-568-50 710 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 07/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/11/2016 Labeler - Save A Lot (095484572) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(46994-568)