Label: INODERM STYLE ANTIBACTERIAL- chloroxylenol liquid
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NDC Code(s):
58575-523-07,
58575-523-10,
58575-523-17,
58575-523-42, view more58575-523-80, 58575-523-82
- Packager: Inopak, Ltd
- 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 February 19, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INODERM STYLE ANTIBACTERIAL
chloroxylenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58575-523 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.3 g in 100 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCO DIETHANOLAMIDE (UNII: 92005F972D) DMDM HYDANTOIN (UNII: BYR0546TOW) ALCOHOL (UNII: 3K9958V90M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ISOPROPYL ALCOHOL (UNII: ND2M416302) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58575-523-42 3800 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2021 07/22/2024 2 NDC:58575-523-07 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2021 10/08/2023 3 NDC:58575-523-17 532 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2021 07/19/2024 4 NDC:58575-523-80 1 in 1 BOX 04/20/2021 01/28/2024 4 800 mL in 1 POUCH; Type 0: Not a Combination Product 5 NDC:58575-523-82 2000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/20/2021 04/21/2024 6 NDC:58575-523-10 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/20/2021 11/06/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/20/2021 07/22/2024 Labeler - Inopak, Ltd (194718243) Establishment Name Address ID/FEI Business Operations Inopak, Ltd 194718243 manufacture(58575-523)