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Leader Poison Ivy Wash pramoxine hydrochloride lotion 10 mg/mL Lotion, 177 mL — NDC 70000-0398-1 (Billing 70000-0398-01)

by Cardinal Health, 110 dba Leader · 177 mL in 1 CONTAINER

This is a package of 177 mL of Leader Poison Ivy Wash pramoxine hydrochloride lotion 10 mg/mL Lotion from Cardinal Health, 110 dba Leader, marketed since Feb 2019 and currently FDA-listed; retail pharmacies pay about $0.0403 per mL (NADAC). It is this product's only package size.

NDC 70000-0398-01
🏷️ FDA NDC (as labeled) 70000-0398-1 billing pads the package segment with a zero
OTC 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 70000-0398-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70000 labeler · 0398 product · 1 package
Package marketed since
Feb 15, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
177 mL per package
Barcode (UPC)
0096295135114
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0398-1
Product NDC 70000-0398
11-digit billing NDC 70000039801
NCPDP billing unit ML — per mL (volume)
RxCUI 1247251
UNII 88AYB867L5
UPC 0096295135114
Application # M017
SPL Set ID 81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-02-15
Route TOPICAL
Dosage form LOTION
Substance PRAMOXINE HYDROCHLORIDE

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

GPI-14 90950000004100
GPI class Poison Ivy Wash
GCN Seq No 068871
GCN 31766
HICL code 002977
Ingredient (HICL) Pramoxine Hcl
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 Q5H
Therapeutic class — specific (HIC3) Topical Local Anesthetics
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name POISON IVY WASH 1% CLEANSER
FDB brand name Poison Ivy Wash
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 068871
  • GCN: 31766
  • GPI-14 (Medi-Span): 90950000004100
  • HICL (First Databank): 002977
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 1247251
Why two NDCs? The FDA registers this code as 70000-0398-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70000-0398-01. 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 Local anesthetics class.

Drug family (ATC) Local anesthetics, Anesthetics for topical use
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 POISON IVY WASH 1% CLEANSER Ingredient Pramoxine Hcl
📗 Our plain-language guide HelloPharmacist
  • It gives short-term relief from pain and itching from minor problems like sunburn, minor burns, insect bites, and poison ivy rashes. Some products are made for specific uses, like...
  • That depends on the product. Many say not more than 3 to 4 times daily, and some allow up to 5 times daily. Check your label and follow it closely.
  • No. It is for external use only. If it gets in your eyes, rinse thoroughly with water.
  • Can I use it inside the vagina or near my eyes?
📖 Read our full Pramoxine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 mLPer package
Retail pharmacies payNADAC · weekly $0.040 $7.13 / 177 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Jun 2026 Jul 2026 Sep 2026 $0.040 $0.040
Flat over the last 5 months.
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
70000-0398-01 You're viewing this Main listing 177 mL in 1 CONTAINER 2019-02-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Poison Ivy Wash 10 mg/mLthis 70000-0398-01 Cardinal 177 ml $0.040 — Availability likely —
Poison Ivy Wash 10 mg/mL 63868-0877-06 Chain 177 ml — — FDA listed —
Terramed Just Think Comfort GynoCare BV Guard Intimate Wash 1 g/100mL 83004-0040-01 Rida 150 ml — — FDA listed —
Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION 10 mg/mL 83004-0045-01 Rida 150 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Feb 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 Q7AO2R1M0B
    Ammonium lauryl sulfate is a mild detergent and foaming agent derived from plant oils. It helps mix water and oil-based ingredients together and creates a light foam in topical formulations like shampoos and cleansers.
  • UNII H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 13W7MDN21W
    A waxy compound made from glycol and stearic acid. It's used as an emulsifier to help blend oil and water-based ingredients, and as a thickener to give the medicine its desired texture and consistency.
  • UNII UDR641JW8W
    A plant-derived oil from jojoba seeds that has been broken down into smaller components. It acts as an emollient and skin-conditioning agent to help soften and smooth the product's texture.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 48Q180SH9T
    Nonoxynol-9 is a surfactant, a chemical that reduces surface tension. In medicines, it acts as an emulsifier or solubilizer, helping mix ingredients that normally don't combine well, and may also serve as a preservative or antimicrobial agent.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesInactive Ingredients: Water Ammonium Lauryl Sulfate Distearyl Phthalic Acid Amide Glycol Distearate Cocamide MIPA Propylene Glycol Diazolidinyl Urea Methylparaben Propylparaben Glycerin Jojoba Esters Disodium EDTA Sodium Hydroxide Nonxynol-9

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.

Manufacturer & labeler

LabelerCardinal Health, 110 dba Leader
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedFeb 2019
Product typeHuman Otc Drug
Portfolio34 products on file

More NDCs from Cardinal Health, 110 dba Leader labeler code 70000

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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

For temporary relief of pain and itching associated with poison ivy, poison oak, poison sumac.

⏱️ Dosage and Administration 35 words ▾

Adults and children 2 years of age and older: Wet the affected area Apply product to affected skin and surrounding area work foam into a lather and rub for up to 3 minutes, if needed

⚠️ Warnings 21 words ▾

When using this product: avoid contact with eyes do not leave on skin longer than 3 minutes rinse thoroughly after application

🧪 Active Ingredient 3 words ▾

Pramoxine HCl 1%

🧪 Inactive Ingredients 28 words ▾

Inactive Ingredients: Water Ammonium Lauryl Sulfate Distearyl Phthalic Acid Amide Glycol Distearate Cocamide MIPA Propylene Glycol Diazolidinyl Urea Methylparaben Propylparaben Glycerin Jojoba Esters Disodium EDTA Sodium Hydroxide Nonxynol-9

🎯 Purpose 2 words ▾

External Analgesic

📄 Keep Out of Reach of Children 23 words ▾

Keep out of reach of children . In case of accidental ingestion, week professional assistance or contact a poison control center immediately. (1-800-222-1222)

📄 Package Label / Principal Display Panel 1 words ▾

ivywash

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0397-01 · Cardinal 70000-0399-01 · Cardinal →
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.