Home › NDC Lookup › Ingredients › Pyrithione Zinc › 83004-0034-01
🧴image loading
(from DailyMed)

Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief PYRITHIONE ZINC 1 g/100mL Shampoo

by Rida LLC · 1 BOTTLE, PLASTIC in 1 CARTON (83004-034-01) / 200 mL in 1 BOTTLE, PLASTIC
NDC 83004-0034-01
🏷️ FDA NDC (as labeled) 83004-034-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 83004-034-01
Product NDC 83004-034
11-digit billing NDC 83004003401
RxCUI 209884
UNII R953O2RHZ5
Application # M032
SPL Set ID d1e4dee7-5962-4ec1-ab99-9d547077b2f2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-28
Route TOPICAL
Dosage form SHAMPOO
Substance PYRITHIONE ZINC
Why two NDCs? The FDA registers this code as 83004-034-01 — 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 → 83004-0034-01. 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 Other dermatologicals class.

Drug family (ATC) Other dermatologicals
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

LabelerRida LLC
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code83004
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio47 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter shampoo formulated with pyrithione zinc, a topical antifungal and antibacterial agent. Pyrithione zinc is commonly used in hair care products to help address fungal and yeast-related scalp conditions, such as those that may contribute to dandruff or itching. The product is applied to the scalp and hair during bathing and is regulated as an OTC monograph drug, meaning it follows established FDA guidelines for this category of over-the-counter products.

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 WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII 6SO6U10H04
    Biotin is a B-vitamin used as a nutritional supplement in some medications. It may also serve as a colorant or marker in formulations.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII G46579QK1M
    A protein-derived ingredient made from keratin, the natural structural protein found in hair. It functions as a film-former and conditioner in topical products, helping to coat and soften the skin or hair.
  • UNII 71M78END5S
    A natural fat derived from fish or algae sources. It's included as a nutritional ingredient and helps distribute other components evenly throughout the medicine.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII YM0K64F20V
    A synthetic emulsifier derived from polyethylene glycol and glucose. It helps blend oil and water-based ingredients together and improves the texture and spreadability of the product.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII 0L414VCS5Y
    A synthetic polymer used as a film-former and conditioning agent. It helps create a protective coating on hair or skin surfaces and improves texture and manageability in topical formulations.
  • UNII 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • UNII O9W3D3YF5U
    A synthetic surfactant derived from petroleum-based olefins. It helps dissolve or suspend active ingredients and other substances in liquid formulations, improving how the medicine mixes and flows.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesascorbic acid, biotin, cocamidopropyl betaine, green tea (camellia sinensis) leaf extract, hydrolyzed keratin, oxidized keratin, panthenol, PEG-120 methyl glucose dioleate, peppermint (mentha piperita) oil, phospholipids, polyquaternium-7, rosemary (rosmarinus officinalis) leaf oil, sodium C14-16 olefin sulfonate, tea tree (melaleuca alternifolia) leaf oil, tocopheryl acetate, trolamine, water.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
Pert Plus 2 in 1 Anti-Dandruff 1 g/100mL 81277-0801-13 TCP 400 ml — — FDA listed —
Head and Shoulders 2in1 Advanced Scalp Care 2in1 1 g/100mL 84126-0022-11 The 1180 ml — — FDA listed —
Head and Shoulders 2in1 Men Coastal Tide 1 g/100mL 84126-0024-37 The 370 ml — — FDA listed —
Head and Shoulders Moisturizing Avocado Oil 2in1 1 g/100mL 84126-0055-37 The 370 ml — — FDA listed —
Head and Shoulders Bare Minimal Ingredients Pure Clean 2in1 1 g/100mL 84126-0073-01 The 2 bottles — — FDA listed —
Head and Shoulders Coconut Daily 1 g/100mL 69423-0315-25 The 250 ml — — FDA listed —
Head and Shoulders 2in1 Men Advanced Series Full and Thick 1 g/100mL 69423-0329-38 The 380 ml — — Discontinued —
Head and Shoulders Aloe Vera Soothing Relief Daily 1 g/100mL 84126-0053-37 The 370 ml — — FDA listed —
Head and Shoulders Hydrating Coconut 2in1 1 g/100mL 84126-0219-37 The 370 ml — — FDA listed —
Head and Shoulders Smooth and Silky 2in1 1 g/100mL 37000-0095-12 The 1280 ml — — Discontinued —
Head and Shoulders MEN Old Spice Pure Sport 1 g/100mL 69423-0294-38 The 380 ml — — Discontinued —
Head and Shoulders Men Advanced Series Refreshing 2in1 Menthol 1 g/100mL 69423-0312-37 The 370 ml — — FDA listed —
Head and Shoulders Classic Clean with Vitamin E 1 g/100mL 69423-0647-11 The 1150 ml — — FDA listed —
Head and Shoulders Bare Minimal Ingredients 1 g/100mL 69423-0721-40 The 350 ml — — FDA listed —
Head and Shoulders Bare Minimal Ingredients Total Scalp Care 1 g/100mL 84126-0259-83 The 835 ml — — FDA listed —
Head and Shoulders Itchy Scalp 1 g/100mL 37000-0079-01 The 2 bottles — — FDA listed —
Head and Shoulders Dry Scalp Care 2in1 1 g/100mL 37000-0093-01 The 2 bottles — — FDA listed —
Head and Shoulders Coconut 2in1 1 g/100mL 69423-0316-01 The 2 bottles — — Discontinued —
Head and Shoulders Supreme Color Protect 1 g/100mL 69423-0346-35 The 350 ml — — FDA listed —
Head and Shoulders Tea Tree Oil Daily 1 g/100mL 69423-0416-01 The 2 bottles — — Discontinued —
Head and Shoulders Moisturizing Avocado Oil 1 g/100mL 69423-0589-38 The 380 ml — — FDA listed —
Head and Shoulders MEN Advanced Series Lavender Mint 2in1 1 g/100mL 69423-0619-38 The 380 ml — — Discontinued —
Head and Shoulders 2in1 Dry Scalp Care with Almond and Coconut Oil 1 g/100mL 69423-0648-11 The 1150 ml — — FDA listed —
Head and Shoulders 2in1 Classic Clean 1 g/100mL 37000-0070-12 The 1280 ml — — Discontinued —
Head and Shoulders Green Apple 2in1 1 g/100mL 37000-0078-02 The 2 bottles — — FDA listed —
Suave Professionals Men 2 in 1 Classic Clean AntiDandruff 1 g/100mL 64942-1353-01 Conopco 828 ml — — FDA listed —
Head and Shoulders Supreme Nourish and Smooth 1 g/100mL 69423-0344-35 The 350 ml — — FDA listed —
Head and Shoulders Supreme Soothe and Strengthen 1 g/100mL 69423-0345-35 The 350 ml — — FDA listed —
Head and Shoulders Scalp Restore 1 g/100mL 69423-0646-11 The 1150 ml — — FDA listed —
Head and Shoulders Ginger 2in1 1 g/100mL 69423-0670-37 The 370 ml — — FDA listed —
Mielle Lavender and Lychee Scalp Moisturizing 1 g/100mL 84126-0256-35 The 355 ml — — FDA listed —
Head and Shoulders Itchy Scalp 2in1 1 g/100mL 37000-0081-25 The 250 ml — — FDA listed —
Head and Shoulders Smooth and Silky 1 g/100mL 37000-0094-10 The 10 ml — — FDA listed —
Head and Shoulders Charcoal Daily 1 g/100mL 69423-0278-37 The 370 ml — — FDA listed —
Head and Shoulders Men Advanced Series Swagger Old Spice 1 g/100mL 69423-0326-37 The 370 ml — — FDA listed —
Head and Shoulders MEN Advanced Series Sandalwood 2in1 1 g/100mL 69423-0415-38 The 380 ml — — Discontinued —
Head and Shoulders Apple Cider Vinegar 1 g/100mL 69423-0521-37 The 370 ml — — FDA listed —
Head and Shoulders 2in1 MEN Citrus and Cedar 1 g/100mL 84126-0023-37 The 370 ml — — FDA listed —
Head and Shoulders Aloe Vera Soothing Relief 2in1 1 g/100mL 84126-0054-37 The 370 ml — — FDA listed —
Head and Shoulders 2in1 Men Vanilla and Amber 1 g/100mL 84126-0082-37 The 370 ml — — FDA listed —
Head and Shoulders Dry Scalp Complete Hydration 2in1 1 g/100mL 84126-0180-11 The 1150 ml — — FDA listed —
Head and Shoulders Green Apple 1 g/100mL 37000-0077-02 The 2 bottles — — FDA listed —
Head and Shoulders 2in1 Men Advanced Series Pure Sport Old Spice 1 g/100mL 69423-0293-01 The 2 bottles — — Discontinued —
Head and Shoulders Men Advanced Series Refreshing Menthol 1 g/100mL 69423-0311-37 The 370 ml — — FDA listed —
Head and Shoulders Deep Scalp Hydration 2in1 1 g/100mL 69423-0696-37 The 370 ml — — FDA listed —
First Aid Beauty Anti-Dandruff 1 g/100mL 69423-0591-23 The 236.5 ml — — FDA listed —
Head and Shoulders Shea Butter 1 g/100mL 69423-0671-37 The 370 ml — — FDA listed —
Nioxin PRO CLINICAL SCALP RECOVERY purifying 1 g/100mL 82157-0011-10 Wella 1000 ml — — FDA listed —
Head and Shoulders Bare Minimal Ingredients Itchy Scalp Relief 1 g/100mL 84126-0074-40 The 400 ml — — FDA listed —
Head and Shoulders Bare Minimal Ingredients Sensitive Scalp Care 1 g/100mL 84126-0154-01 The 2 bottles — — FDA listed —
Head and Shoulders Hydrating Coconut 1 g/100mL 84126-0218-25 The 250 ml — — FDA listed —
Head and Shoulders Dry Scalp Care 1 g/100mL 37000-0092-01 The 2 bottles — — FDA listed —
MOISTURIZING DANDRUFF 1% Pyrithione Zinc 1 g/100mL 54111-0169-50 Bentley 236 ml — — FDA listed —
Head and Shoulders MEN Advanced Series Bourbon 2in1 1 g/100mL 69423-0412-38 The 380 ml — — Discontinued —
Head and Shoulders Apple Cider Vinegar 2in1 1 g/100mL 69423-0522-12 The 1280 ml — — Discontinued —
Royal Oils by Head and Shoulders Sulfate Free Scalp Care 1 g/100mL 69423-0608-38 The 380 ml — — FDA listed —
Head and Shoulders Lemon Oil 2in1 1 g/100mL 69423-0620-40 The 400 ml — — Discontinued —
Head and Shoulders Deep Scalp Cleanse Daily 1 g/100mL 69423-0697-37 The 370 ml — — FDA listed —
Head and Shoulders Deep Scalp Cleanse 2in1 1 g/100mL 69423-0698-37 The 370 ml — — FDA listed —
Head and Shoulders Classic Clean 1 g/100mL 37000-0071-01 The 10 ml — — Discontinued —
Head and Shoulders Classic Clean Dandruff 1 g/100mL 67751-0053-01 Navajo 1 bottle — — FDA listed —
Head and Shoulders Deep Scalp Hydration Daily 1 g/100mL 69423-0672-37 The 370 ml — — FDA listed —
Head and Shoulders 2in1 MenTimber Old Spice 1 g/100mL 84126-0089-37 The 370 ml — — FDA listed —
Head and Shoulders Deep Moisture 1 g/100mL 69423-0247-38 The 380 ml — — Discontinued —
Head and Shoulders 2in1 Men Advanced Series Swagger Old Spice 1 g/100mL 69423-0327-01 The 2 bottles — — FDA listed —
Head and Shoulders Supreme Detox and Hydrate 1 g/100mL 69423-0343-35 The 350 ml — — FDA listed —
Head and Shoulders Tea Tree Oil 2in1 1 g/100mL 69423-0417-12 The 1280 ml — — Discontinued —
Head and Shoulders Bare Minimal Ingredients Soothing Hydration 1 g/100mL 69423-0722-40 The 400 ml — — FDA listed —
Balancing 1 g/100mL 73528-0110-01 Zero 280 ml — — FDA listed —
Head and Shoulders Hutchs Cooling Rush 1 g/100mL 84126-0263-37 The 370 ml — — FDA listed —
Head and Shoulders Polamalu s Hall of Fame Hair 1 g/100mL 84126-0265-37 The 370 ml — — FDA listed —
Head and Shoulders Double Coverage 2in1 1 g/100mL 84126-0264-37 The 370 ml — — FDA listed —
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief 1 g/100mLthis 83004-0034-01 Rida 1 bottle — — 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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief (this brand).

Top reported reactions

Death2
Dehydration2
Drug Interaction2
Headache2
Nausea2
Periproctitis2
Pyrexia2

Age at onset

Adult2
Elderly2

Reporter sex

29 reports

Serious outcomes

Hospitalization10
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 7 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
83004-0034-01 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (83004-034-01) / 200 mL in 1 BOTTLE, PLASTIC 2026-07-28 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — 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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 83004-034-01, 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: 83004-0034-01, written without dashes as 83004003401. 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 83004-0034-01, the first segment (83004) is the labeler code FDA assigned to Rida LLC; the middle segment (0034) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Rida LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rida 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 17 words ▾

Uses helps relieve and control the recurrence of flaking and itching associated with dandruff and seborrheic dermatitis.

⏱️ Dosage and Administration 31 words ▾

Directions for best results use at least twice a week or as directed by a doctor; wet hair, massage a generous amount onto the scalp, then rinse thoroughly; repeat if desired.

⚠️ Warnings 66 words ▾

Warnings For external use only When using this product Avoid contact with eyes If contact occurs, rinse the eyes thoroughly with water. Stop use and ask a doctor if: Condition worsen or does not improve in 2-4 weeks after regular use of this product as directed. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient Pyrithione zinc 1%

🧪 Inactive Ingredients 47 words ▾

Inactive ingredients ascorbic acid, biotin, cocamidopropyl betaine, green tea (camellia sinensis) leaf extract, hydrolyzed keratin, oxidized keratin, panthenol, PEG-120 methyl glucose dioleate, peppermint (mentha piperita) oil, phospholipids, polyquaternium-7, rosemary (rosmarinus officinalis) leaf oil, sodium C14-16 olefin sulfonate, tea tree (melaleuca alternifolia) leaf oil, tocopheryl acetate, trolamine, water.

🎯 Purpose 2 words ▾

Purpose Anti-dandruff

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