INOFOAM Antibacterial
- Manufacturer
- Inopak, Ltd
- Effective date
- 2023-02-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:36:17
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Chloroxylenol 0.3% w/w
OTC - PURPOSE SECTION
Purpose
Antiseptic
INDICATIONS & USAGE SECTION
Uses
- Handwash to help reduce bacteria on the skin that potentially can cause disease.
- Recommended for repeated use.
WARNINGS SECTION
Warnings
For external use only
OTC - WHEN USING SECTION
When using this product keep out of eyes. In case of eye contact, flush eyes with water.
OTC - STOP USE SECTION
Stop use and ask a doctor if irritation and redness develop or if condtion persists for more than 72 hours.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
- Wash both hands thoroughly for 15 seconds.
- Rince under running water and dry thoroughly.
INACTIVE INGREDIENT SECTION
Inactive ingredients Water, Sodium Laureth Sulfate, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, Phenoxyethanol, Isopropyl Alcohol, Fragrance, Citric Acid, FD&C Red No. 4
SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INOFOAM
Antibacterial Foaming Hand Wash
With 0.3% Chloroxylenol
33.8 fl. oz. (1000 mL)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58575-516-01 | 2023-02-19 | C162847 | 48780-1 | f386c649-a1fd-0266-e053-dadaa90a7c1a | INOFOAM Antibacterial Foaming Hand Wash |
| 58575-516-11 | 2023-02-19 | C162847 | 48780-1 | f386c649-a1fd-0266-e053-dadaa90a7c1a | INOFOAM Antibacterial Foaming Hand Wash |
| 58575-516-18 | 2023-02-19 | C162847 | 48780-1 | f386c649-a1fd-0266-e053-dadaa90a7c1a | INOFOAM Antibacterial Foaming Hand Wash |
| 58575-516-42 | 2023-02-19 | C162847 | 48780-1 | f386c649-a1fd-0266-e053-dadaa90a7c1a | INOFOAM Antibacterial Foaming Hand Wash |
| 58575-516-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-a1fd-0266-e053-dadaa90a7c1a | INOFOAM Antibacterial Foaming Hand Wash |
| 58575-516-11 | 2023-01-30 | C162847 | 48780-1 | f386c649-a1fd-0266-e053-dadaa90a7c1a | INOFOAM Antibacterial Foaming Hand Wash |
| 58575-516-18 | 2023-01-30 | C162847 | 48780-1 | f386c649-a1fd-0266-e053-dadaa90a7c1a | INOFOAM Antibacterial Foaming Hand Wash |
| 58575-516-42 | 2023-01-30 | C162847 | 48780-1 | f386c649-a1fd-0266-e053-dadaa90a7c1a | INOFOAM Antibacterial Foaming Hand Wash |
Products#
Every source-derived product name is available through these pages.
- INOFOAM Antibacterial Foaming Hand Wash
- Chloroxylenol
- CITRIC ACID MONOHYDRATE
- COCO DIETHANOLAMIDE
- DMDM HYDANTOIN
- ALCOHOL
- FD&C RED NO. 4
- ISOPROPYL ALCOHOL
- PHENOXYETHANOL
- SODIUM LAURETH SULFATE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58575-516 | 58575-516-01, 58575-516-18, 58575-516-42, 58575-516-11 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| COCO DIETHANOLAMIDE | 92005F972D | IACT |
| DMDM HYDANTOIN | BYR0546TOW | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| FD&C RED NO. 4 | X3W0AM1JLX | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| SODIUM LAURETH SULFATE | BPV390UAP0 | IACT |
| WATER | 059QF0KO0R | IACT |
| CHLOROXYLENOL | 0F32U78V2Q | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f5177ac5-c749-3703-e053-2995a90a0119 | bb66f952-235a-0aef-e053-2a95a90a4723 | 2023-02-19 | Warnings | f5177ac5-c749-3703-e053-2995a90a0119 bb66f952-235a-0aef-e053-2a95a90a4723 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
