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Steritalc 2g Talc 2 g/50mL Powder — NDC 62327-0222-42 package photo

Steritalc 2g Talc 2 g/50mL Powder

by Novatech SA · 4 VIAL, GLASS in 1 BOX (62327-222-42) / 50 mL in 1 VIAL, GLASS (62327-222-02)
NDC 62327-0222-42
🏷️ FDA NDC (as labeled) 62327-222-42 billing pads the product segment with a zero
Rx only Brand 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) 62327-222-42
Product NDC 62327-222
11-digit billing NDC 62327022242
NCPDP billing unit EA — each (per item)
RxCUI 2003393, 2003398, 2003400, 2003402, 2003403, 2003405
UNII 7SEV7J4R1U
UPC 0362327444449, 0362327222429, 0362327333439
Application # NDA205555
SPL Set ID c94e51d9-beef-4b06-e053-2a95a90a754a
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-11-01
Route INTRAPLEURAL
Dosage form POWDER
Substance TALC
GPI-14 45500070002920
GPI class Steritalc
GCN Seq No 064326
GCN 13286
HICL code 002321
Ingredient (HICL) Talc
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1S
Therapeutic class — specific (HIC3) Intrapleural Sclerosing Agents, Antineoplast. Adj.
AHFS code 24:12.00.00
AHFS class Sclerosing Agents
FDB label name STERITALC 2 GRAM VIAL
FDB brand name Steritalc
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 62327-222-42 — 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 → 62327-0222-42. 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.

🏭 Manufacturer & labeler

LabelerNovatech SA
Application holderNOVATECH SA
FDA applicationNDA205555 (NDA)
Labeler code62327
First marketedNov 2017
Product typeHuman Prescription Drug
Portfolio3 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 STERITALC 2 GRAM VIAL Ingredient Talc

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.
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
Steritalc 2g 2 g/50mLthis 62327-0222-42 Novatech 4 vials — — 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

🏛️
2017
On the market since
Nov 2017
📍
2026
Currently FDA-listed
9 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 Steritalc 2g (this brand).

Top reported reactions

Exposure To Chemical Pollution305
Pain257
Anxiety222
Injury198
Mesothelioma176
Disability130
Emotional Distress92

Reporter sex

420 reports
Male · 53%
Female · 47%

Serious outcomes

Disabling188
Death108
Life-threatening9
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 283 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
62327-0222-42 You're viewing this 4 VIAL, GLASS in 1 BOX (62327-222-42) / 50 mL in 1 VIAL, GLASS (62327-222-02) 2017-11-01 Active

🧭 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 FDA registers it as 62327-222-42, 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: 62327-0222-42, written without dashes as 62327022242. 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 62327-0222-42, the first segment (62327) is the labeler code FDA assigned to Novatech SA; the middle segment (0222) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (42) 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 Novatech SA. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Novatech SA 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 83 words ▾

1.INDICATIONS AND USAGE 1.INDICATIONS AND USAGE

1.1Malignant Pleural Effusion STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion.

1.2Pneumothorax STERITALC is indicated in adults to decrease the recurrence of pneumothorax. ___________ INDICATIONS AND USAGE__ __________ STERITALC® is a sclerosing agent indicated: To decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. (1.1) In adults to decrease the recurrence of pneumothorax. (1.2)

⏱️ Dosage and Administration ~3 min read ▾

2. DOSAGE AND ADMINISTRATION

2.1Important Use Information STERITALC is for pleurodesis only - Do NOT administer STERITALC intravenously. Administer STERITALC after adequate drainage of the pleural effusion or air.

2.2Recommended Dose for Malignant Pleural Effusion The recommended dose for malignant pleural effusion is 2 to 5 grams administered intrapleurally. According to the physician’s discretion, and in consideration of diagnosis and patient’s condition, different dosages may be applied, but a total dosage of 10 grams should not be exceeded.

2.3Recommended Dose for Pneumothorax The recommended dose for pneumothorax is 2 grams administered intrapleurally. According to physician’s discretion and in consideration of diagnosis and patient’s condition, different dosages may be applied, but a cumulative dosage of 10 grams should not be exceeded.

2.4Preparation Slurry for Tube Thoracostomy STERITALC 2 grams and 4 grams dosage forms Do not prepare the slurry in advance. Use the slurry immediately after preparation. Prepare the talc suspension using aseptic technique in an appropriate laminar flow hood as follows: Step 1 : Fully bend or remove the flap into the direction of the arrow.

The top can now be punctured to mix the slurry. Step 2 : Using a 16 gauge needle attached to a 60-mL Luer Lok syringe, draw up 50 mL of 0.9 % Sodium Chloride injection, USP. Vent the talc bottle using a needle.

Slowly inject the 50 mL of 0.9% Sodium Chloride Injection, USP into the glass vial. Step 3: Swirl the glass vial to disperse the talc powder. Step 4 : Divide the contents of the glass vial equally into two 60-mL Luer Lok syringes, each attached with a 16 gauge needle, by withdrawing 25 mL of the suspension into each syringe with continuous swirling.

Add 0.9% Sodium Chloride Injection, USP to a total volume of 50 mL in each syringe. Draw 10 mL of air into each syringe to the 60 mL mark to serve as a headspace for mixing prior to administration. For STERITALC 2 grams, each syringe should contain 1 gram of Sterile Talc Powder in 50 mL of 0.9% Sodium Chloride Injection, USP with an air headspace of 10 mL.

For STERITALC 4 grams, each syringe should contain 2 grams of Sterile Talc Powder in 50 mL of 0.9% Sodium Chloride Injection, USP with an air headspace of 10 mL. Step 5: Label the syringes with the talc concentration, the expiration date and time, the identity of the patient intended to receive the material, and the following statements: “SHAKE SYRINGE WELL to resuspend before administration” “FOR PLEURODESIS ONLY – not for intravenous administration” Step 6: If not used immediately, store prepared suspension in refrigerator.

Discard the prepared suspension if not used within 12 hours. Insufflation/Poudrage STERITALC 2 grams and 4 grams dosage forms Use an FDA-approved or cleared device for STERITALC insufflation/poudrage. Step 1: Fully remove the top from the vial.

Step 2 : Fill the content into the applicator for insufflation/poudrage. Step 3 : Follow the selected device manufacturer's instructions for insufflation/poudrage. STERITALC 3 grams dosage form STERITALC 3 grams is designed to be used for the administration of talc in combination with a compatible FDA approved or FDA cleared device intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis such as Novatech SA’s NOVATECH® TALCAIR™.

Step 1 : Remove the aluminum tear-off cap from the vial. Step 2: Remove the stopper from the vial. Step 3 : Close the vial with the vial coupling.

Step 4 : Firmly press the vial coupling onto the vial until you feel and hear the lid "click" onto the vial top. To do this, place the vial on a firm and level base. Step 5 : Connect the insufflation bulb to the vial coupling using the Luer lock connector.

Step 6 : Ensure that all components are firmly connected with each other.

2.5Administration Slurry for Tube Thoracostomy STERITALC 2 grams and 4 grams dosage forms Prior to administration, continuously agitate the syring…

💊 Dosage Forms and Strengths 100 words ▾

3. DOSAGE FORMS AND STRENGTHS White or off-white to light gray sterile powder provided in the following strengths: Powder, for intrapleural use: STERITALC, 2 grams in a 50 mL single-dose vial Powder, for intrapleural use: STERITALC, 4 grams in a 50 mL single-dose vial Powder, for intrapleural use: STERITALC, 3 grams in a 10 mL single-dose vial, for use with Novatech SA’s NOVATECH® TALCAIR™ _______ DOSAGE FORMS AND STRENGTHS_ ______ Powder: 2 grams, in a 50 mL single-dose vial (3) Powder: 4 grams, in a 50 mL single-dose vial (3) Powder: 3 grams, in a 10 mL single-dose vial (3)

⛔ Contraindications 40 words ▾

4. CONTRAINDICATIONS Due to lead content, STERITALC® is contraindicated in pregnant women and can cause fetal harm and potential loss of pregnancy [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)]. _____________ CONTRAINDICATIONS_ ____________ Pregnancy. (4, 5.3, 8.1)

⚠️ Warnings and Cautions ~2 min read ▾

5. WARNINGS AND PRECAUTIONS

5.1Pneumonitis and Acute Respiratory Distress Syndrome (ARDS) Acute Pneumonitis and ARDS, including fatal cases, have been reported with intrapleural use of various talc products. Systemic exposure of talc could be affected by the integrity of the visceral pleura and could be increased if talc is administered immediately after mechanical abrasion or biopsy of the pleura. The literature also suggests a possible correlation between talc particle size distribution and risk of toxicity.

There are published reports of two large, prospective trials conducted to evaluate the safety of STERITALC administered intrapleurally. One trial evaluated 558 patients treated with STERITALC 4g by poudrage for MPE. The second trial evaluated 418 patients with recurrent primary spontaneous pneumothorax treated with STERITALC 2 g by poudrage.

No cases of ARDS or talc-related lung injury were reported.

5.2Interference with Future Procedures Sclerosis of the pleural space may preclude or complicate subsequent ipsilateral surgery and diagnostic procedures. Consider the possible effects of the use of STERITALC on future diagnostic and therapeutic procedures prior to administration.

5.3Lead Content Lead is present in STERITALC as an impurity. The main target organ for lead toxicity is the nervous system, but effects of lead exposure also include increased blood pressure, anemia, decreased sperm production, and damage to the kidneys in children and adults. Minimal risk levels of lead have not been derived for humans because clear thresholds for effects have not been identified.

Children are more sensitive to lead toxicity than adults, and no safe blood level has been determined in children. Cognitive and neurobehavioral deficits are observed in children exposed to lead. Exposure of a pregnant woman to lead may cause miscarriage, premature birth, lower birth weights and slow or impaired mental development in the child.

Administration of STERITALC at the highest recommended dose of 10 grams may deliver up to 40 mcg of lead.

5.4Asbestos Content Talc products may contain trace amounts of asbestos. Asbestos is a known human carcinogen. Exposure to asbestos may increase the risk of mesotheliomas and other cancers including lung, larynx, and ovarian cancer.

STERITALC is tested for asbestos and asbestiform fibers [see DESCRIPTION (11)]. _ ______WARNINGS AND PRECAUTIONS _____________ Pneumonitis and Acute Respiratory Distress Syndrome (ARDS): Acute Pneumonitis and ARDS, have been reported with intrapleural use of various talc products. (5.1) Interference with Future Procedures: Sclerosis of the pleural space may preclude or complicate subsequent ipsilateral surgery and diagnostic procedures. (5.2) Lead Content: STERITALC® contains lead as an impurity.

May cause lead toxicity, especially in children. (5.3) Asbestos Content: Talc products may contain trace amounts of asbestos. Exposure to asbestos may increase the risk of mesotheliomas and other cancers.

(5.4, 11)

🤒 Adverse Reactions 115 words ▾

6. ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling. Pneumonitis and Acute Respiratory Distress Syndrome (ARDS) [see Warnings and Precautions (5.1)] Lead Content [see Warnings and Precautions (5.3)] Asbestos Content [see Warnings and Precautions (5.4)] Common adverse reactions observed with intrapleural use of various talc products are fever and pain.

Other adverse reactions include dyspnea, arrhythmia, empyema, pneumonitis and acute respiratory distress syndrome (ARDS). Procedure related adverse reactions such as bleeding, hemothorax, wound infections, atelectasis and pneumonia may occur. _____________ ADVERSE REACTIONS _____________ Common adverse reactions are fever and pain. (6) To report suspected adverse reactions contact Boston Medical Product Inc., at 508-898-9300 and FDA at 1-800-332-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~2 min read ▾

8. USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary STERITALC is contraindicated for use in pregnant women because it contains lead, which can cause fetal harm and potential loss of pregnancy [see Warnings and Precautions (5.3)] . There are no human data on the use of STERITALC in pregnant women. In an animal reproduction study, oral administration of talc in pregnant rabbits during organogenesis revealed no evidence of teratogenicity at dose up to approximately 5 times the human dose [see Data] .

Data Animal Data In an embryo-fetal developmental toxicity study in rabbits, talc was administered to rabbits by oral gavage daily during the period of organogenesis at doses up to 900 mg/kg (approximately 5 times the human dose on a mg/m2 basis). No significant dose-related toxicity was reported except at maternally toxic doses. In multiple animal studies, intrapleurally administered talc was not absorbed systemically.

8.2Lactation Risk Summary There is no information regarding the presence of talc in human milk, the effects on the breastfed infants, or the effects on milk production. STERITALC contains lead, which is known to have adverse effects on health and development in neonates, infants and children [see Warnings and Precautions (5.3)] . Because of the potential for serious adverse reactions in breast-fed infants from lead content in STERITALC, advise lactating women not to breastfeed during treatment with STERITALC and for 5 months after the final dose.

8.3Females and Males of Reproductive Potential Contraception STERITALC contains lead, which can cause fetal harm when administered to a pregnant woman [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment and for 5 months following the final dose of STERITALC. Infertility STERITALC contains lead, which may impair fertility in males of reproductive potential [see Warnings and Precautions (5.3)].

8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients. Lead is present in STERITALC as an impurity [see Warnings and Precautions (5.3)]. ------------USE IN SPECIFIC POPULATIONS -------------- Females and Males of Reproductive Potential: Advise females of reproductive potential to use effective contraception. (8.3) Lactation: Advise women not to breastfeed. (8.2)

🧬 Clinical Pharmacology 39 words ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism of Action Talc instilled into the pleural cavity is thought to result in an inflammatory reaction. This reaction promotes adherence of the visceral and parietal pleura to prevent reaccumulation of pleural air or fluid.

📦 How Supplied / Storage and Handling 154 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING STERITALC, white or off-white to light gray, sterile powder is supplied as two grams of talc powder in a single-dose 50 mL Type III glass vial, closed with a stopper, and crimped with an aluminum cap; with 4 vials packaged in one carton. NDC 62327-222-02 (vial) NDC 62327-222-42 (carton) four grams of talc powder in a single-dose 50 mL Type III glass vial, closed with a stopper, and crimped with an aluminum cap; with 4 vials packaged in one carton.

NDC 62327-444-04 (vial) NDC 62327-444-44 (carton) three grams of talc powder in a single-dose 10 mL Type I brown glass vial, closed with a stopper, and crimped with an aluminum cap; with 4 vials packaged in one carton. NDC 62327-333-03 (vial) NDC 62327-333-43 (carton) Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect against sunlight.

📋 Description 135 words ▾

11. DESCRIPTION STERITALC (talc) is a sclerosing agent for intrapleural administration. The molecular formula for talc is Mg3Si4O10(OH)2.

The molecular weight is 379.3 g/mole. The chemical name of talc is hydrated magnesium silicate. The talc powder contains ≥ 95% of hydrated magnesium silicate; associated minerals include chlorites (hydrated aluminum and magnesium silicates), magnesite (magnesium carbonate), calcite (calcium carbonate), and dolomite (calcium and magnesium carbonate).

The talc elementary sheet is composed of a layer of magnesium-oxygen/hydroxyl octahedra, sandwiched between two layers of silicon-oxygen tetrahedra. Talc is insoluble in water. STERITALC is tested for asbestos and asbestiform fibers consistent with USP standards for talc-containing products.

STERITALC is supplied as 2 grams, 3 grams, and 4 grams white or off-white to light gray, sterile powder. STERITALC contains particle size-controlled talc, graded to decrease the proportion of smaller particles.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62296-8292-02 · Ulta 62327-0333-43 · Novatech →
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.