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Acute-Kare Healthcare Personnel Handwash CHLOROXYLENOL 1 g/100mL Soap, 1000 mL — NDC 11084-0800-41 package photo

Acute-Kare Healthcare Personnel Handwash CHLOROXYLENOL 1 g/100mL Soap, 1000 mL

by SC Johnson Professional USA, Inc. · 1000 mL in 1 BOTTLE (11084-800-41)
NDC 11084-0800-41
🏷️ FDA NDC (as labeled) 11084-800-41 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 11084-800-41
Product NDC 11084-800
11-digit billing NDC 11084080041
RxCUI 413257
UNII 0F32U78V2Q
Application # 505G(a)(3)
SPL Set ID 45e9e9dd-444b-46b1-a522-4ae372e6ff3c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-02-01
Marketing end 2027-12-31
Route TOPICAL
Dosage form SOAP
Substance CHLOROXYLENOL
Why two NDCs? The FDA registers this code as 11084-800-41 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 11084-0800-41. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Phenol and derivatives class.

Drug family (ATC) Phenol and derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSC Johnson Professional USA, Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code11084
First marketedFeb 2018
Product typeHuman Otc Drug
Portfolio16 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Acute-Kare Healthcare Personnel Handwash is a topical soap containing chloroxylenol, an antimicrobial agent. Chloroxylenol is commonly used in handwashing products to help reduce bacteria and germs on the skin. This is an over-the-counter monograph product, meaning it is marketed under FDA's established rules for this category of hand hygiene soap rather than through an individual drug application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 18L9G3U51M
    A gentle cleansing agent derived from coconut oil. It acts as a surfactant and emulsifier, helping mix oil and water-based ingredients together and improve how the product spreads or cleanses on skin.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII 39DK5WQ2PR
    A synthetic polymer made from methacrylate, methoxy polyethylene glycol, maleate, and styrene. It's used as a coating or binder to control how quickly the medicine dissolves and releases its active ingredients in the body.
  • UNII 6F36Q0I0AC
    PEG-150 distearate is a waxy substance made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and surfactant to help blend water and oil-based ingredients, and may also function as a thickener or lubricant in the formulation.
  • UNII 0L414VCS5Y
    A synthetic polymer used as a film-former and conditioning agent. It helps create a protective coating on hair or skin surfaces and improves texture and manageability in topical formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 632GS99618
    Sodium lauroyl sarcosinate is a mild, plant-derived cleaning agent used in medicines as a surfactant and emulsifier. It helps mix oil and water-based ingredients and may aid tablet disintegration.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

9 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesAqua (Water), Propylene Glycol, Sodium Lauroyl Sarcosinate, PEG-150 Distearate, Disodium Cocoamphodiacetate, Polyquaternium-7, Tetrasodium EDTA, Acrylates/PEG-10 Maleate/Styrene Copolymer, Citric Acid, Parfum (Fragrance).

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Kindest Kare Hand Antimicrobial Handwash 1 g/100mL 11084-0036-41 SC 1000 ml — — FDA listed —
Acute-Kare Healthcare Personnel Handwash 1 g/100mLthis 11084-0800-41 SC 1000 ml — — FDA listed —
DigiClean E 1 mg/100mL 47593-0308-41 Ecolab 750 ml — — FDA listed —
Ecolab 10 mg/mL 47593-0506-41 Ecolab 750 ml — — FDA listed —
VioNexus 1 g/100mL 55443-0600-03 Metrex 2 bottles — — FDA listed —
SoftenSure Foam Antimicrobial 10 mg/mL 59900-0127-05 Best 1250 ml — — FDA listed —
Soften Sure Foam Antimicrobial 10 g/1000mL 59900-0211-06 Best 1000 ml — — FDA listed —
Prestige 10 mg/mL 63621-0335-14 Sunburst 3785 ml — — FDA listed —
FoamyIQ Healthcare Personnel Handwash 10.11 g/L 64009-0203-06 Spartan 1.25 l — — FDA listed —
Lite nFoamy Healthcare Personnel Handwash 10.11 g/L 64009-0335-82 Spartan 532 l — — FDA listed —
Antiseptic Hand Cleaner 10.11 g/L 64009-0336-85 Spartan 3.79 l — — FDA listed —
Clean Xpress Antiseptic Hand Cleaner 10 mg/mL 64009-0338-02 Spartan 1000 ml — — FDA listed —
Soft Care Defend Foam Antibacterial Handwash 1 g/100mL 64536-8308-02 Diversey, 1200 ml — — Discontinued —
Soft Care Defend Antibacterial Handwash 1 g/100mL 64536-8748-02 Diversey, 1200 ml — — Discontinued —
Soft Care Defend Antibacterial Handwash 10 g/L 64536-8760-02 Diversey, 3.78 l — — FDA listed —
WhiskCare 365 10 mg/mL 65585-0365-02 Whisk 3785 ml — — FDA listed —
AFCO 5508 Sanifect Foam-E II 2081980 mg/208198mL 66949-0139-01 Zep 208198 ml — — FDA listed —
AFCO 5508 Sanifect Foam-E II 2081980 mg/208198mL 66949-0141-01 Zep 208198 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2018
On the market since
Feb 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Acute-Kare Healthcare Personnel Handwash (this brand).

Top reported reactions

Vomiting2
Abdominal Pain Lower1
Abdominal Pain Upper1
Anaemia1
Cholecystitis1
Cystitis1
Drug Effect Decreased1

Age at onset

Elderly1

Reporter sex

7 reports
Male · 14%
Female · 86%

Serious outcomes

Hospitalization3
Life-threatening1
Death1
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
11084-0800-41 You're viewing this 1000 mL in 1 BOTTLE (11084-800-41) 2018-02-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 11084-800-41, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 11084-0800-41, written without dashes as 11084080041. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 11084-0800-41, the first segment (11084) is the labeler code FDA assigned to SC Johnson Professional USA, Inc.; the middle segment (0800) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (41) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but SC Johnson Professional USA, Inc. has reported a marketing end date of 2027-12-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
SC Johnson Professional USA, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 19 words ▾

Uses Antiseptic Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatment.

⏱️ Dosage and Administration 24 words ▾

Directions wet skin and spread a small amount on the hands wash hands, rinse thoroughly with water, and repeat as necessary between patient contacts

⚠️ Warnings 80 words ▾

Warnings For external use only When using this product do not get it in the eyes; this product causes eye irritation upon direct contact. In case of eye exposure, rinse thoroughly with water. If eye irritation persists, contact a physician.

Stop use and ask a doctor if irritation and redness develop and symptoms persist for more than 3 days. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

🧪 Active Ingredient 4 words ▾

Active ingredient Chloroxylenol 1.0%

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients Aqua (Water), Propylene Glycol, Sodium Lauroyl Sarcosinate, PEG-150 Distearate, Disodium Cocoamphodiacetate, Polyquaternium-7, Tetrasodium EDTA, Acrylates/PEG-10 Maleate/Styrene Copolymer, Citric Acid, Parfum (Fragrance).

🎯 Purpose 2 words ▾

Purpose Antiseptic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 11084-0309-12 · SC 11084-0802-80 · SC →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.