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Salicylic Acid 60 mg/g Gel

by Acella Pharmaceuticals, LLC · 1 TUBE in 1 CARTON (42192-134-40) / 40 g in 1 TUBE
NDC 42192-0134-40
🏷️ FDA NDC (as labeled) 42192-134-40 billing pads the product segment with a zero
Rx only 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) 42192-134-40
Product NDC 42192-134
11-digit billing NDC 42192013440
NCPDP billing unit GM — per gram (weight)
RxCUI 312893
UNII O414PZ4LPZ
SPL Set ID 996ad0d5-d635-4ed4-8263-d7f773260421
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-05-19
Route TOPICAL
Dosage form GEL
Substance SALICYLIC ACID
GPI-14 90750030004005
GPI class Salicylic Acid
GCN Seq No 015725
GCN 22713
HICL code 002465
Ingredient (HICL) Salicylic Acid
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5A
Therapeutic class — specific (HIC3) Keratolytics
AHFS code 84:28.00.00
AHFS class Keratolytic Agents
FDB label name SALICYLIC ACID 6% GEL
FDB brand name Salicylic Acid
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 42192-134-40 — 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 → 42192-0134-40. 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 Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
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

LabelerAcella Pharmaceuticals, LLC
Labeler code42192
First marketedMay 2011
Product typeHuman Prescription Drug
Portfolio36 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

Label name SALICYLIC ACID 6% GEL Ingredient Salicylic Acid
📗 Our plain-language guide HelloPharmacist
  • It's designed to treat acne. Salicylic acid helps by loosening and removing dead skin cells that clog pores — the buildup that leads to breakouts. The multi-step system on this lab...
  • What is this salicylic acid product actually supposed to do for my skin?
  • Some mild tingling, stinging, and peeling is actually expected — that's the salicylic acid doing its job by clearing away dead skin cells. But if the burning or peeling feels exces...
  • My skin feels like it's burning and peeling. Is that normal?
📖 Read our full Salicylic Acid Topical guide →

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 RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • 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.

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

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 $5.78 $231.15 / 40 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
Keralyt 6 g/100g 11086-0030-10 Summers 100 g — — FDA listed —
Salicylic Acid 60 mg/gthis 42192-0134-40 Acella 1 tube — — FDA listed —
Salicylic Acid 6% Gel 6 g/100mL 59088-0261-03 PureTek 29.57 ml — — FDA listed —
Salicylic Acid 6% Gel 6 g/100g 71085-0073-60 IPG 1 bottle — — Discontinued —
Salycim 60 mg/g 59088-0227-05 PURETEK 57 g — — 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

🏛️
2011
On the market since
May 2011
📍
2026
Currently FDA-listed
15 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 42192-0134-40, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
948
Units reimbursed last 4 qtrs
40.3K
Gross reimbursed last 4 qtrs
$233.1K
Avg / prescription
$245.91
Avg / unit
$5.7788
Latest quarter Q4 2025
278Rx
Fee-for-service vs managed care ⓘ
24% FFS 76% MCO
Fee-for-service · 229 Rx Managed care · 719 Rx
State Medicaid map
Alaska: 2,121 units · 289 per 100k residents AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 520 units · 8.8 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 5,280 units · 42.1 per 100k residents IL Indiana: no data reported IN Ohio: 12,040 units · 102 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: 440 units · 7.5 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 5,260 units · 116 per 100k residents KY West Virginia: 1,040 units · 58.8 per 100k residents WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 3,883 units · 107 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,840 units · 24.8 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 3,160 units · 44.3 per 100k residents TN North Carolina: 840 units · 7.8 per 100k residents NC South Carolina: 480 units · 8.9 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 960 units · 8.7 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 2,477 units · 11.0 per 100k residents FL
Units reimbursed · per 100k residents
7.5289
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Alaska 289 /100k
2 Kentucky 116 /100k
3 Connecticut 107 /100k
4 Ohio 102 /100k
5 West Virginia 58.8 /100k
6 Tennessee 44.3 /100k
7 Illinois 42.1 /100k
8 Arizona 24.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Salicylic Acid — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Salicylic Acid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.2K
Claims incl. refills
43
Beneficiaries
35
Spend / beneficiary
$319.01
Spend / claim
$259.66
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 SALICYLIC ACID — the ingredient across all brands.

Top reported reactions

Dry Skin12,766
Erythema12,318
Acne11,763
Skin Burning Sensation11,557
Skin Irritation7,730
Skin Exfoliation5,759
Rash4,766

Age at onset

Neonate7
Infant1
Child16
Adolescent30
Adult334
Elderly131

Reporter sex

52,595 reports
Male · 27%
Female · 73%
Unknown · 0%

Serious outcomes

Hospitalization800
Life-threatening214
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 1,272 111
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
42192-0134-40 You're viewing this 1 TUBE in 1 CARTON (42192-134-40) / 40 g in 1 TUBE 2011-05-19 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 — Not published for this NDC No photo available yet for this listing.
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) ✓ Available
“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 "Unapproved Drug Other". 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 42192-134-40, 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: 42192-0134-40, written without dashes as 42192013440. 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 42192-0134-40, the first segment (42192) is the labeler code FDA assigned to Acella Pharmaceuticals, LLC; the middle segment (0134) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (40) 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 Acella Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Acella Pharmaceuticals, LLC 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 27 words ▾

INDICATIONS AND USAGE For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with psoriasis or thickened skin of palms and soles, corns and calluses.

⏱️ Dosage and Administration 121 words ▾

DOSAGE AND ADMINISTRATION The preferable method of use is to apply Salicylic Acid 6% Gel thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed a bland cream or lotion may be applied.

Once clearing is apparent, the occasional use of Salicylic Acid 6% Gel will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. Unless hands are being treated, hands should be rinsed thoroughly after application.

⛔ Contraindications 39 words ▾

CONTRAINDICATIONS Salicylic Acid 6% Gel should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% Gel should not be used in children under 2 years of age.

⚠️ Warnings 168 words ▾

WARNINGS Contact with eyes, lips, broken or inflamed skin, and all mucous membranes should be avoided. Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present.

In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. In the event of salicylic acid toxicity, the use of Salicylic Acid 6% Gel should be discontinued. Fluids should be administered to promote urinary excretion.

Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Considering the potential of developing Reye’s syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician.

🤒 Adverse Reactions 15 words ▾

ADVERSE REACTIONS Excessive erythema and scaling conceivably could result from use on open skin lesions.

🔄 Drug Interactions ~1 min read ▾

Drug Interactions. (The following interactions are from a published review 5 and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salicylic Acid 6% Gel is not known.) I.

Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: Drug Description of Interaction Tolbutamide; Sulfonylureas Hypoglycemia potentiated Methotrexate Decrease tubular reabsorption; clinical toxicity from methotrexate can result Oral Anticoagulants Increased bleeding II. Drugs changing salicylate levels by altering renal tubular reabsorption: Drug Description of Interaction Corticosteroids Decreases plasma salicylate level; tapering doses of steroids may promote salicylism Ammonium Sulfate Increases plasma salicylate level III.

Drugs with complicated interactions with salicylates: Drug Description of Interaction Heparin Salicylate decreases platelet adhesivesness and interferes with hemostasis in heparin-treated patients Pyrazinamide Inhibits pyrazinamide-induced hyperuricemia Uricosuric Agents Effect of probenecid, sulfinpyrazone and phenylbutazone inhibited The following alterations of laboratory tests have been reported during salicylate therapy 6 : Laboratory Tests Effect of Salicylates Thyroid Function Decreased PBI; increased T 3 uptake Urinary Sugar False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2 - 5 g qd) 5 Hydroxyindole Acetic Acid False negative with fluorometric test Acetone, Ketone Bodies False positive FeCl 3 in Gerhardt reaction; red color persists with boiling 17-OH Corticosteroids False reduced values with >4.8 g qd salicylate Vanilmandelic Acid False reduced values Uric Acid May increase or decrease depending on dose Prothrombin Decreased levels; slightly increased prothrombin time

🤰 Pregnancy ~1 min read ▾

Pregnancy (Category C) - Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent 4 times the maximum daily human dose of salicylic acid (as supplied in one tube, 40 g of Salicylic Acid 6% Gel) when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women.

Salicylic Acid 6% Gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Nursing Mothers - It is not known whether topically applied salicylic acid is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering Salicylic Acid 6% Gel to nursing mothers and nursing mothers should certainly not apply Salicylic Acid 6% Gel to the chest area or any other part of the body with which the nursing child’s mouth is likely to come in contact.

Because of the potential for serious advers reactions in nursing infants from the mother’s use of Salicylic Acid 6% Gel, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🆘 Overdosage 3 words ▾

OVERDOSAGE See WARNINGS

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Salicylic acid has been shown to produce desquamation of the horny layer of skin while not affecting qualitative or quantitative changes in structure of the viable epidermis. 1,2 The mechanism of action has been attributed to dissolution of intercellular cement substance. 3 In a study of the percutaneous absorption of salicylic acid from Salicylic Acid 6% Gel in four patients with extensive active psoriasis, Taylor and Halprin 4 showed that peak serum salicylate levels never exceeded 5 mg/100 mL even though more than 60% of the applied salicylic acid was absorbed.

Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100mL). Peak serum levels occurred within 5 hours of the topical application under occlusion. The sites were occluded for 10 hours over the entire body surface below the neck.

Since salicylates are distributed in the extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space. 5 (See PRECAUTIONS ). The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%), and free salicylic acid (6%).

4 The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more glucuronides and less salicyluric and salicylic acid. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space. 5 Fifty to eighty percent of salicylate is protein bound to albumin.

Salicylates compete with the binding of several drugs and can modify the action of these drugs. By similar competetive mechanisms other drugs can influence the serum levels of salicylate. (See PRECAUTIONS ).

📦 How Supplied / Storage and Handling 19 words ▾

HOW SUPPLIED Salicylic Acid 6% Gel is supplied in a 40 gram plastic tube bearing the NDC Number 42192-134-40.

📦 Storage and Handling 16 words ▾

Store at controlled room temperature 15° - 30°C (59° - 86°F). [See USP “Controlled Room Temperature”]

📋 Description 61 words ▾

DESCRIPTION Salicylic Acid 6% Gel is applied topically and used in the removal of excessive keratin in hyperkeratotic skin disorders. Each gram of Salicylic Acid 6% Gel contains salicylic acid 6% as the active ingredient, and the following inactive ingredients: hydroxypropylcellulose and propylene glycol. CHEMICAL STRUCTURE Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following chemical structure: STRUCTURE

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 42192-0133-16 · Acella 42192-0135-10 · Acella →
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.