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PANRETIN alitretinoin 60 mg/60g Gel, 60 g — NDC 59212-0601-22 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PANRETIN alitretinoin 60 mg/60g Gel, 60 g — NDC 59212-601-22 (Billing 59212-0601-22)

by Advanz Pharma (US) Corp. · 60 g in 1 TUBE

This is a package of 60 g of PANRETIN alitretinoin 60 mg/60g Gel from Advanz Pharma (US) Corp., marketed since Sep 2019 and currently FDA-listed. It is this product's only package size.

NDC 59212-0601-22
🏷️ FDA NDC (as labeled) 59212-601-22 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 59212-601-22 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59212 labeler · 601 product · 22 package
Package marketed since
Sep 10, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
60 g per package
Barcode (UPC)
0359212601223
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59212-601-22
Product NDC 59212-601
11-digit billing NDC 59212060122
NCPDP billing unit GM — per gram (weight)
RxCUI 213502, 313847
UNII 1UA8E65KDZ
UPC 0359212601223
Application # NDA020886
SPL Set ID 49c16717-7d86-4257-80c9-baa1417e5555
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-09-10
Route TOPICAL
Dosage form GEL
Substance ALITRETINOIN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90376015004020
GPI class Panretin
GCN Seq No 041643
GCN 94350
HICL code 019074
Ingredient (HICL) Alitretinoin
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5N
Therapeutic class — specific (HIC3) Topical Antineoplastic Premalignant Lesion Agents
AHFS code 84:18.00.00
AHFS class Antiproliferants
FDB label name PANRETIN 0.1% GEL
FDB brand name Panretin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 041643
  • GCN: 94350
  • GPI-14 (Medi-Span): 90376015004020
  • HICL (First Databank): 019074
  • AHFS class code: 84:18.00.00
  • RxCUI (RxNorm): 213502
Why two NDCs? The FDA registers this code as 59212-601-22 — 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 → 59212-0601-22. 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 Retinoid class.

Pharmacologic class Retinoid
Drug family (ATC) Agents for dermatitis, excluding corticosteroids, Retinoids for cancer treatment
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.

Clinical

Label name PANRETIN 0.1% GEL Ingredient Alitretinoin
📖 What it is MedlinePlus · NLM

Alitretinoin is used to treat skin lesions associated with Kaposi's sarcoma (a type of cancer that causes skin lesions). Alitretinoin is in a class of medications called retinoids. It works by stopping the growth of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Panretin (alitretinoin) gel treats skin lesions from AIDS-related Kaposi’s sarcoma in adults. It isn’t meant for people who need whole-body KS treatment, such as those with many ne...
  • Coat each lesion fully, usually twice a day. Your prescriber may slowly raise this to four times a day if your skin handles it. Keep it off healthy skin and mucous surfaces, don’t...
  • Skin irritation at the spot is most common. That can mean redness, scaling, burning, itching, tingling, peeling or swelling. If irritation gets severe, call your doctor. They may h...
  • No. It can harm an unborn baby, so tell your doctor right away if you could be or become pregnant. Use effective birth control during treatment and for 1 week after your last dose....
📖 Read our full Alitretinoin guide →
1
Nutrient depletion considerations

Alitretinoin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Alitretinoin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

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 · Q2 2026 $109.85 $6,590.99 / 60 g
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
59212-0601-22 You're viewing this Main listing 60 g in 1 TUBE 2019-09-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Panretin 60 mg/60gthis 59212-0601-22 Advanz 60 g — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2019
On the market since
Sep 2019
📍
2026
Currently FDA-listed
7 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.

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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.

4 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.

Manufacturer & labeler

LabelerAdvanz Pharma (US) Corp.
Application holderADVANZ PHARMA (US) CORP
FDA applicationNDA020886 (NDA)
Labeler code59212
First marketedSep 2019
Product typeHuman Prescription Drug
Portfolio20 products on file

More NDCs from Advanz Pharma (US) Corp. labeler code 59212

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 102 words ▾

1 INDICATIONS AND USAGE

1.1Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) [see Clinical Studies ( 14.1 )] . PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS).

Limitations of Use : PANRETIN GEL is not indicated when systemic anti-Kaposi’s sarcoma therapy is required.

⏱️ Dosage and Administration 148 words ▾

2 DOSAGE AND ADMINISTRATION PANRETIN GEL is for topical use only. Do not use occlusive dressings with PANRETIN GEL. Apply PANRETIN GEL twice daily to coat the entire cutaneous Kaposi sarcoma lesions.

Gradually increase the application frequency up to four (4) times a day as tolerated. Continue PANRETIN GEL as long as patient is deriving benefit. Reduce application frequency for application site toxicity.

Interrupt treatment for severe irritation; may resume at a reduced application frequency once symptoms improve. Avoid application of gel to normal skin and do not apply on or near mucosal surfaces. Wash hands after application unless gel is applied to Kaposi sarcoma lesions on the hands.

Allow gel to dry for three to five minutes before covering with clothing. • Apply to the affected lesions twice daily; increase to 4 times daily as tolerated. ( 2 ) • For topical use only. ( 2 )

💊 Dosage Forms and Strengths 18 words ▾

3 DOSAGE FORMS AND STRENGTHS Topical Gel: 0.1% alitretinoin (clear yellow gel) in a 60-gram tube. Gel, 0.1%

⛔ Contraindications 35 words ▾

4 CONTRAINDICATIONS PANRETIN GEL is contraindicated in patients with a known hypersensitivity to retinoids or to any of the ingredients of the product. Hypersensitivity to retinoids or any component of PANRETIN GEL ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS • Embryo-Fetal Toxicity : Can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception. ( 5.1 . 8.1 , 8.3 ) • Photosensitivity : Minimize exposure to sunlight and sunlamps. ( 5.2 ) • DEET toxicity : Do not use DEET-containing products ( 5.3 )

5.1Embryo-Fetal Toxicity Based on data from animal studies and its mechanism of action, PANRETIN GEL can cause fetal harm when administered to a pregnant woman. Oral administration of alitretinoin to pregnant animals during the period of organogenesis was teratogenic and embryo-lethal at exposures 5 times the estimated daily human topical dose. Advise women of the potential risk to a fetus.

Advise women of reproductive potential to use effective contraception during treatment with PANRETIN GEL and for 1 week after the last dose [see Use in Specific Populations ( 8.1 , 8.3 )] .

5.2Photosensitivity Retinoids as a class have been associated with photosensitivity. Advise patients to minimize exposure of treated areas to sunlight and sunlamps during the use of PANRETIN GEL.

5.3Toxicity with DEET-Containing Products Animal toxicology studies showed increased DEET toxicity when DEET was included as part of the formulation. Advise patients to not use PANRETIN GEL concurrently with products that contain DEET (N,N-diethyl-m-toluamide), a common component of insect repellent products.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Photosensitivity [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (> 5%) at the application site are rash, pain, paresthesia, pruritis, exfoliative dermatitis, edema, and skin disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Advanz Pharma (US) Corp. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PANRETIN GEL was assessed in two multicenter, prospective, randomized, double-blind, vehicle-controlled trials (Trial 1 and Trial 2) in patients with cutaneous lesions of AIDS-related KS [see Clinical Studies ( 14.1 )] .

In a pooled analysis of both trials, the most common adverse reactions in ≥ 5% of patients were rash, pain, paresthesia, pruritis, exfoliative dermatitis, edema, and skin disorder. In Trial 1, severe local skin adverse reactions (erythema and edema with or without vesiculation) occurred in 10% of patients during the first 12 weeks of treatment (versus 0% in the vehicle control). Adverse reactions led to withdrawal from the study in 7% of patients.

In Trial 2, severe local skin adverse reactions (erythema and edema with or without vesiculation) occurred in 6% of patients during the first 12 weeks of treatment (versus 0% in the vehicle control) and 1 patient withdrew due to severe skin irritation. Table 1 lists the most common application site adverse reactions that occurred in a least 5% of patients during the double-blind phase who received PANRETIN GEL in either of the two controlled studies. TABLE 1: Adverse Reactions at Application Site in Trial 1 and 2 in ≥ 5% of Patients Treated with PANRETIN GEL A dverse Event Term Trial 1 Trial 2 PANRETIN GEL N=134 % Vehicle Gel N=134 % PANRETIN GEL N=36 % Vehicle Gel N=46 % Rash 1 77 11 25 4 Pain 2 34 7 0 4 Pruritus 3 11 4 8 4 Exfoliative dermatitis 4 9 2 3 0 Skin disorder 5 8 1 0 0 Edema 6 8 3 3 0 Parethesia 7 3 0 22 7 Includes Investigator terms: 1 Erythema, scaling, irritation, redness, rash, dermatitis 2 Burning, pain 3 Itching, pruritus 4 Flaking, peeling, desquamation, exfoliation 5 Excoriation, cracking, scab, crusting, drainage, eschar, fissure or oozing 6 Edema, swelling, inflammation 7 Stinging, tingling

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy : Can cause fetal harm ( 8.1 ) • Lactation: Advise not to breastfeed ( 8.2 )

8.1Pregnancy Risk Summary Based on findings in animal studies and its mechanism of action, PANRETIN GEL can cause fetal harm when administered to a pregnant woman. Oral administration of alitretinoin to pregnant animals during the period of organogenesis was teratogenic and embryo lethal at exposures at least 5 times the estimated daily human topical dose ( see Data ). There are no data on the use of PANRETIN GEL in pregnant women.

Advise pregnant women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Oral administration of alitretinoin to pregnant rabbits during the period of organogenesis resulted in early resorptions, post-implantation loss, and fetal defects (limb, craniofacial, fused sternebrae) at doses ≥ 0.5 mg/kg/day (approximately 5 times the estimated daily human topical dose based on body surface area, assuming complete systemic absorption of alitretinoin, when PANRETIN GEL is administered as a 60 g tube over 1 month in a 60 kg human).

Early resorptions and post-implantation loss also occurred in rats administered oral alitretinoin at doses ≥5 mg/kg/day (approximately 25 times the estimated daily human topical dose based on body surface area). Limb and craniofacial defects also occurred in mice administered oral alitretinoin on day 11 of gestation at single doses ≥50 mg/kg (approximately 127 times the estimated daily human topical dose based on body surface area).

8.2Lactation Risk Summary It is not known whether alitretinoin or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions from PANRETIN GEL in the nursing child, advise patients that breastfeeding is not recommended during treatment with PANRETIN GEL and for 1 week after the last dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to initiating PANRETIN GEL. Contraception Females PANRETIN GEL can cause embryo-fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential to use effective contraception during treatment with PANRETIN GEL and for 1 week after the last dose.

Males Advise males with female partners of reproductive potential to use effective contraception during treatment with PANRETIN GEL and for 1 week after the last dose.

8.4Pediatric Use The safety and effectiveness of PANRETIN GEL have not been established in pediatric patients.

8.5Geriatric Use Clinical studies of PANRETIN GEL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger adult patients.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on findings in animal studies and its mechanism of action, PANRETIN GEL can cause fetal harm when administered to a pregnant woman. Oral administration of alitretinoin to pregnant animals during the period of organogenesis was teratogenic and embryo lethal at exposures at least 5 times the estimated daily human topical dose ( see Data ). There are no data on the use of PANRETIN GEL in pregnant women.

Advise pregnant women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Oral administration of alitretinoin to pregnant rabbits during the period of organogenesis resulted in early resorptions, post-implantation loss, and fetal defects (limb, craniofacial, fused sternebrae) at doses ≥ 0.5 mg/kg/day (approximately 5 times the estimated daily human topical dose based on body surface area, assuming complete systemic absorption of alitretinoin, when PANRETIN GEL is administered as a 60 g tube over 1 month in a 60 kg human).

Early resorptions and post-implantation loss also occurred in rats administered oral alitretinoin at doses ≥5 mg/kg/day (approximately 25 times the estimated daily human topical dose based on body surface area). Limb and craniofacial defects also occurred in mice administered oral alitretinoin on day 11 of gestation at single doses ≥50 mg/kg (approximately 127 times the estimated daily human topical dose based on body surface area).

🧒 Pediatric Use 17 words ▾

8.4Pediatric Use The safety and effectiveness of PANRETIN GEL have not been established in pediatric patients.

🧓 Geriatric Use 29 words ▾

8.5Geriatric Use Clinical studies of PANRETIN GEL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger adult patients.

🧬 Clinical Pharmacology 165 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Alitretinoin (9-cis-retinoic acid) is a naturally occurring endogenous retinoid that binds to and activates all known intracellular retinoid receptor subtypes (RARα, RARβ, RARγ, RXRα, RXRβ and RXRγ). Once activated these receptors function as transcription factors that regulate the expression of genes that control the process of cellular differentiation and proliferation in both normal and neoplastic cells. Alitretinoin inhibits the growth of Kaposi’s sarcoma (KS) cells in vitro.

12.2Pharmacodynamics Alitretinoin exposure-response relationships and the time course of pharmacodynamic response are unknown.

12.3Pharmacokinetics The range of 9-cis-retinoic acid plasma concentrations in patients with cutaneous lesions of AIDS-related KS after multiple daily applications of PANRETIN GEL for up to 60 weeks was similar to the range of circulating, naturally occurring 9-cis-retinoic acid plasma concentrations in untreated healthy participants. Elimination Metabolism 9-cis-retinoic acid is metabolized to 4-hydroxy-9-cis-retinoic acid and 4-oxo-9-cis-retinoic acid by CYP2C9, 3A4, 1A1, and 1A2. 4-oxo-9-cis-retinoic acid is the major circulating metabolite following oral administration of 9-cis-retinoic acid.

🧬 Mechanism of Action 71 words ▾

12.1Mechanism of Action Alitretinoin (9-cis-retinoic acid) is a naturally occurring endogenous retinoid that binds to and activates all known intracellular retinoid receptor subtypes (RARα, RARβ, RARγ, RXRα, RXRβ and RXRγ). Once activated these receptors function as transcription factors that regulate the expression of genes that control the process of cellular differentiation and proliferation in both normal and neoplastic cells. Alitretinoin inhibits the growth of Kaposi’s sarcoma (KS) cells in vitro.

📦 How Supplied / Storage and Handling 54 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING PANRETIN GEL is a clear yellow gel and is supplied in a 60-gram tubes containing 0.1% alitretinoin. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. PANRETIN GEL is flammable; keep away from heat or flame.

📋 Description 125 words ▾

11 DESCRIPTION PANRETIN GEL is a retinoid. PANRETIN GEL 0.1% contains alitretinoin and is intended for topical application only. The chemical name is (2E,4E,6Z,8E)-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid, also known as 9-cis-retinoic acid.

Chemically, alitretinoin is related to vitamin A. It is a yellow powder with a molecular weight of 300.44 and a molecular formula of C 20 H 28 O 2 . It is slightly soluble in ethanol (7.01 mg/g at 25℃) and insoluble in water.

The structural formula of alitretinoin is as follows: PANRETIN GEL is a clear, yellow gel containing 0.1% (w/w) alitretinoin. Each gram of PANRETIN GEL contains 1 mg alitretinoin. PANRETIN GEL contains the following inactive ingredients: butylated hydroxytoluene NF, dehydrated alcohol USP 92%, hydroxypropyl cellulose NF, and polyethylene glycol 400 NF. alitretinion

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Embryo-Fetal Toxicity Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform females of the risk to a fetus and potential loss of pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )].

Advise females of reproductive potential to use effective contraception during treatment and for 1 week after the last dose of PANRETIN GEL [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week following the last dose of PANRETIN GEL [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.3 )] . Lactation Advise patients not to breastfeed during treatment with PANRETIN GEL and for 1 week after the last dose of PANRETIN GEL [see Use in Specific Populations ( 8.2 )].

Photosensitivity Advice patients that PANRETIN GEL can cause photosensitivity and to avoid sunlight and sunlamps and use measures such as protective clothing in PANRETIN-applied areas [see Warnings and Precautions ( 5.2 )]. Toxicity with DEET-Containing Products Advise patients to avoid DEET-containing products such as insect repellant while using PANRETIN GEL [see Warnings and Precautions ( 5.3 )]. Manufactured for: Advanz Pharma (US) Corp.

Bannockburn IL, 60015 PANRETIN ® is a registered trademark of Mercury Pharma Group Limited. Distributed by Advanz Pharma (US) Corp. under license Revised: 11/2025 PATIENT INFORMATION PANRETIN GEL (PAN-reh-tin) (alitretinoin) Important information: PANRETIN GEL is for use on skin (topical use) only. Do not use PANRETIN GEL in or near your eyes, inside your nose, mouth, lips, vagina, tip of the penis, rectum, or anus.

What is PANRETIN GEL? PANRETIN GEL is a prescription medicine used to treat skin lesions in adults with AIDS-related Kaposi’s sarcoma (KS). PANRETIN GEL is not used to treat KS when a medicine taken by mouth or injection (systemic treatment) is needed.

It is not known if PANRETIN GEL is safe and effective in children. Do not use PANRETIN GEL if you are allergic to retinoids or any of the ingredients in PANRETIN GEL. See the end of this Patient Information leaflet for a complete list of ingredients in PANRETIN GEL.

Before using PANRETIN GEL, tell your healthcare provider about all of your medical conditions, including if you: • are pregnant or plan to become pregnant. PANRETIN GEL can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with PANRETIN GEL.

Females who are able to become pregnant: o Your healthcare provider should check to see if you are pregnant before you start treatment with PANRETIN GEL. o You should use effective birth control (contraception) during treatment and for 1 week after the last dose of PANRETIN GEL. Males with female partners who are able to become pregnant: o You should use effective birth control (contraception) during treatment and for 1 week after the last dose of PANRETIN GEL. • are breastfeeding or plan to breastfeed. It is not known if PANRETIN GEL passes into your breast milk.

Do not breastfeed during treatment and for 1 week after your last dose of PANRETIN GEL. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider about skin products that you use.

You should not use products that contain DEET (N, N-diethyl-m-toluamide), during treatment with PANRETIN Gel. DEET is an ingredient commonly found in insect repellent. How should I use PANRETIN GEL?

Use PANRETIN GEL exactly as your healthcare provider tells you to use it. To open the PANRETIN GEL, remove the cap and use the point of the cap to puncture the metal safety seal. Apply… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics 77 words ▾

12.3Pharmacokinetics The range of 9-cis-retinoic acid plasma concentrations in patients with cutaneous lesions of AIDS-related KS after multiple daily applications of PANRETIN GEL for up to 60 weeks was similar to the range of circulating, naturally occurring 9-cis-retinoic acid plasma concentrations in untreated healthy participants. Elimination Metabolism 9-cis-retinoic acid is metabolized to 4-hydroxy-9-cis-retinoic acid and 4-oxo-9-cis-retinoic acid by CYP2C9, 3A4, 1A1, and 1A2. 4-oxo-9-cis-retinoic acid is the major circulating metabolite following oral administration of 9-cis-retinoic acid.

🧬 Pharmacodynamics 14 words ▾

12.2Pharmacodynamics Alitretinoin exposure-response relationships and the time course of pharmacodynamic response are unknown.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Kaposi’s Sarcoma PANRETIN GEL was evaluated in two multicenter, randomized, double-blind, vehicle-controlled studies in adult patients with cutaneous lesions of AIDS-related KS. In both studies the primary efficacy objective was the patients’ cutaneous KS tumor response rate through 12 weeks of study drug treatment which was assessed by evaluating from 3 to 8 KS index lesions according to the modified AIDS Clinical Trials Group (ACTG) response criteria as applied to topical therapy (i.e., evaluation of height and area reductions of the index lesions only; progressive disease in non-index lesions and new lesions were not considered progressive disease; progressive disease was scored only in the treated index lesions).

A global evaluation by physicians was also carried out. It considered all the patient’s treated lesions (index and other) compared to baseline. In this evaluation, patients with at least a 50% improvement in the KS lesions were considered responders.

In addition, photographs of lesions in patients considered responders by the modified ACTG criteria were examined by the FDA for a cosmetically beneficial response, defined as at least a 50% improvement in appearance compared to baseline, considering both the KS lesions and dermal toxicity at the lesion site, in at least 50% of the index lesions and maintained for at least 3 weeks. Visceral disease was not monitored in these trials and the appearance of new KS lesions was not considered part of the response assessment.

In Trial 1, a total of 268 patients were entered from centers in the U.S. and Canada. Patients were treated topically three to four times a day with either PANRETIN GEL or a matching vehicle gel for a minimum of 12 weeks, followed by an open-label phase in patients who had not yet progressed on PANRETIN GEL. Median age of patients was 39 years, 99% were men, 75% were White, 16% Hispanic, and 7% Black.

Fifty-seven percent of patients had a CD4+ lymphocyte count <200/mm3 and 36% had CD4+ lymphocyte count less than 100/mm3; 12% had visceral KS. Responses during the double-blind phase are shown in Table 2 . New lesions in untreated areas were seen in about 50% of patients.

Trial 2 was an international study with a planned enrollment of 270 patients. Patients were treated topically twice a day with PANRETIN GEL or a matching vehicle for 12 weeks. The study was stopped early because of positive-interim results in the initial 82 patients.

Median age of patients was 36 years for PANRETIN-GEL and 39 years for matching vehicle; all patients were men; 89% White; 5% Hispanic, and 4% Black; 67% had a CD4+ lymphocyte count ≤200/mm3 and 39% had CD4+ lymphocyte count ≤100/mm3; and 16% had visceral KS. Results of the study are shown in Table 2 . Responses to PANRETIN GEL were seen both in previously untreated patients and in patients with prior systemic and/or topical KS treatment.

Table 2: Response Rates Trial 1 Trial 2 PANRETIN GEL N=134 Vehicle Gel N=134 PANRETIN GEL N=36 Vehicle Gel N=45 Modified ACTG Response 35%* 16% 36% 7% P = 0.0012 Physician’s Global Subjective Assessment (all treated lesions) 19% 4% 47% 11% P = 0.00014 Photograph Response 15% 4% 19% 2% P = 0.0026 *All responses were partial responses except 1% complete response for modified ACTG response in Trial 1. In the clinical trials, the cumulative percentage of patients who experienced a response was less than 1% at 2 weeks, 10% at 4 weeks, and 28% at 8 weeks.

Photographs of some patients revealed an erythematous and edematous response, leading to a cosmetically mixed outcome.

🧪 Nonclinical Toxicology 50 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment Of Fertility Carcinogenicity studies with alitretinoin have not been conducted. Alitretinoin was not mutagenic in vitro (bacterial assay, Chinese hamster ovary cell HGPRT mutation assay) and was not clastogenic in vitro (chromosome aberration test in human lymphocytes) or in vivo (mouse micronucleus test).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 47 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment Of Fertility Carcinogenicity studies with alitretinoin have not been conducted. Alitretinoin was not mutagenic in vitro (bacterial assay, Chinese hamster ovary cell HGPRT mutation assay) and was not clastogenic in vitro (chromosome aberration test in human lymphocytes) or in vivo (mouse micronucleus test).

📄 Package Label / Principal Display Panel 13 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 59212-601-22 Panretin ® gel (alitretinoin) 0.1% tube label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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

Medicare Part D (outpatient prescription) spending for Panretin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Panretin. 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
$264.7K
Claims incl. refills
42
Beneficiaries
29
Spend / beneficiary
$9,129.24
Spend / claim
$6,303.52
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 Alitretinoin — the ingredient across all brands.

Top reported reactions

Drug Intolerance9
Headache9
Hypercholesterolaemia8
Treatment Failure8
Vomiting8
Cough6
Diarrhoea6

Age at onset

Adult28
Elderly7

Reporter sex

117 reports
Male · 42%
Female · 58%

Serious outcomes

Hospitalization27
Life-threatening5
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 23 1
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.

About this NDC listing & data coverage

Finished prescription 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

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Advanz Pharma (US) Corp.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Advanz Pharma (US) Corp. 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.
← 59212-0562-10 · Advanz 59212-0680-10 · Advanz →
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.