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A-Cute Derm B-Kleer Benzethonium Chloride 2 mg/mL Gel, 236.59 mL — NDC 68605-1040-08 package photo

A-Cute Derm B-Kleer Benzethonium Chloride 2 mg/mL Gel, 236.59 mL

by ABBE Laboratories, Inc. · 236.59 mL in 1 BOTTLE, PLASTIC (68605-1040-8)
NDC 68605-1040-08
🏷️ FDA NDC (as labeled) 68605-1040-8 billing pads the package segment with a zero
This package
Contains236.59 mL Pack sizes4 compare ↓
Also comes in: 29.57 mL 68605-1040-09 118.29 ml 68605-1040-04 946.35 ml 68605-1040-02
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) 68605-1040-8
Product NDC 68605-1040
11-digit billing NDC 68605104008
RxCUI 1243889
UNII PH41D05744
Application # M004
SPL Set ID 544333fe-6c3a-485b-b899-e029d97ea962
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-05-01
Route CUTANEOUS
Dosage form GEL
Substance BENZETHONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 68605-1040-8 — a 5-4-1 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 package segment → 68605-1040-08. 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 Antiseptics class.

Drug family (ATC) Antiseptics, Quaternary ammonium compounds
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

LabelerABBE Laboratories, Inc.
FDA applicationM004 (OTC MONOGRAPH DRUG)
Labeler code68605
First marketedMay 2022
Product typeHuman Otc Drug
Portfolio7 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?

A-Cute Derm B-Kleer is a topical gel containing benzethonium chloride, an antimicrobial agent commonly found in over-the-counter skin care products. Benzethonium chloride is typically used to reduce bacteria and other microorganisms on the skin surface. This product is marketed under FDA's over-the-counter monograph rules for its category rather than through individual product approval.

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.

🧪 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 Q7AO2R1M0B
    Ammonium lauryl sulfate is a mild detergent and foaming agent derived from plant oils. It helps mix water and oil-based ingredients together and creates a light foam in topical formulations like shampoos and cleansers.
  • UNII H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 1EO3O1X7HG
    A synthetic antimicrobial compound used as a preservative in medicines to prevent contamination and extend shelf life by inhibiting the growth of bacteria and fungi in liquid formulations.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 603P14DHEB
    A synthetic antimicrobial chemical used as a preservative in topical and cosmetic formulations. It prevents bacterial and fungal growth in products to maintain stability and safety during storage and use.
  • UNII 23D6XVI233
    Lauramidopropyl betaine is a mild cleanser and foaming agent derived from coconut oil. In medicines, it helps create a smooth texture, reduce foam, and improve how the product spreads or mixes.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII AYF4VM3N1Z
    PEG-4 laurate is a synthetic compound made by combining a short polyethylene glycol chain with lauric acid, a natural fatty acid. It acts as an emulsifier and surfactant to help mix oil and water components and improve the texture and stability of the medicine.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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.

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

The official label also statesPurified Water, Ammonium Lauryl Sulfate, Lauramidopropyl Betaine, Hydroxypropyl Bis-Hydroxyethyl-dimonium Chloride, Propylene Glycol, Hydroxypropylmethylcellulose, Sodium Chloride, Diazolidinyl Urea, PEG-4 Laurate, Methylparaben, Propylparaben, 3-iodo-2-propynylbutylcarbamate.

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 gPer 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.
Try another pack size: 29.57 mL 118.29 ml 946.35 ml
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
benzethonium chloride liquid .2 g/100g 37945-0902-08 Bio-Medical 236 g — — FDA listed —
ZylastXP Antiseptic Foaming 2 mg/mL 57362-0467-01 Innovative 244 ml — — FDA listed —
A-Cute Derm B-Kleer 2 mg/mLthis 68605-1040-08 ABBE 236.59 ml — — FDA listed —
A-Cute Derm Antisepation 2 mg/mL 68605-7171-02 ABBE 946.4 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

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 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 Benzethonium Chloride — the ingredient across all brands.

Top reported reactions

Nausea27
Hypersensitivity23
Headache21
Therapeutic Product Effect Decreased17
Diarrhoea15
Contraindicated Product Administered10
Dyspnoea10

Age at onset

Child1
Adult15
Elderly29

Reporter sex

210 reports
Male · 38%
Female · 62%

Serious outcomes

Hospitalization81
Death23
Life-threatening6
Disabling5
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 22 0
Most recent year is provisional (FAERS lags ~3 months).
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
68605-1040-02 946.35 mL in 1 BOTTLE, PLASTIC (68605-1040-2) 2022-05-01 Active
68605-1040-04 118.29 mL in 1 BOTTLE, PLASTIC (68605-1040-4) 2022-05-01 Active
68605-1040-08 You're viewing this 236.59 mL in 1 BOTTLE, PLASTIC (68605-1040-8) 2022-05-01 Active
68605-1040-09 1 BOTTLE, PLASTIC in 1 BOX (68605-1040-9) / 29.57 mL in 1 BOTTLE, PLASTIC (68605-1040-1) 2022-05-01 Active

Pack size FAQ

What quantity is in NDC 68605-1040-08?
NDC 68605-1040-08 contains 236.59 mL — 236.59 ml in 1 bottle, plastic.
What is the difference between NDC 68605-1040-08 and NDC 68605-1040-09?
Both are A-Cute Derm B-Kleer Benzethonium Chloride 2 mg/mL Gel — the drug itself is identical. NDC 68605-1040-08 is the 236.59 mL package, while NDC 68605-1040-09 is the 1 bottle package.
What NDC number is used to bill for this package of A-Cute Derm B-Kleer Benzethonium Chloride 2 mg/mL Gel?
Bill NDC 68605-1040-08 — the 11-digit billing format is 68605104008. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 68605-1040-8, 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: 68605-1040-08, written without dashes as 68605104008. 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 68605-1040-08, the first segment (68605) is the labeler code FDA assigned to ABBE Laboratories, Inc.; the middle segment (1040) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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: this package is listed as actively marketed, with no marketing end date reported by ABBE Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 bottle (68605-1040-09), 118.29 ml (68605-1040-04), 946.35 ml (68605-1040-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
ABBE Laboratories, 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 32 words ▾

Uses B-KLEER™ is a unique, non-drying cleanser. •Designed for all skin types and pH balanced. •Excellent for postoperative care. •May be used as a topical antimicrobial to help protect against skin infection.

⏱️ Dosage and Administration 36 words ▾

Directions •Wet hands and other areas to be treated. •Place a small amount of gel in your hands and work into lather. •Apply lather to areas to be treated using a gentle, circular motion. •Rinse clean.

⚠️ Warnings 38 words ▾

Warnings For external use only. Do not use in eyes. Ask a doctor before use if you have deep wounds or puncture wounds. Stop use and ask a doctor if irritation develops. Keep out of reach of children.

🧪 Active Ingredient 5 words ▾

Active Ingredients Benzethonium Chloride (0.2%)

🧪 Inactive Ingredients 24 words ▾

Inactive Ingredients Purified Water, Ammonium Lauryl Sulfate, Lauramidopropyl Betaine, Hydroxypropyl Bis-Hydroxyethyl-dimonium Chloride, Propylene Glycol, Hydroxypropylmethylcellulose, Sodium Chloride, Diazolidinyl Urea, PEG-4 Laurate, Methylparaben, Propylparaben, 3-iodo-2-propynylbutylcarbamate.

🎯 Purpose 2 words ▾

Purpose Antimicrobial

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68599-9573-01 · McKesson 68605-2001-02 · ABBE →
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.