Label: CHLOROXYLENOL liquid
- NDC Code(s): 55910-984-44, 55910-984-57
- Packager: Old East Main Co
- 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 7, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
-
Inactive ingredients
water, sodium C14-16 olefin sulfonate, lauramine oxide and/or lauramidopropylamine oxide and myristamidopropylamine oxide, sodium laureth sulfate, sodium lauryl sulfate, sodium chloride, sodium xylenesulfonate, alcohol denat., fragrance, limonene, phenoxyethanol, citric acid, methylisothiazolinone, tetrasodium EDTA, yellow 5, red 33
- SPL UNCLASSIFIED SECTION
- principal display panel
-
INGREDIENTS AND APPEARANCE
CHLOROXYLENOL
chloroxylenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-984 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3.09 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 XYLENESULFONATE (UNII: G4LZF950UR) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALCOHOL (UNII: 3K9958V90M) PHENOXYETHANOL (UNII: HIE492ZZ3T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-984-44 532 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 12/01/2020 2 NDC:55910-984-57 1183 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 12/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/01/2020 Labeler - Old East Main Co (068331990) Registrant - Vi-Jon,LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-984)