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Perricone MD Acne Relief Maximum Strength Spot Gel Salicylic Acid 2 g/100g Gel, 1 tube

by THG Beauty USA LLC · 1 TUBE in 1 CARTON (84448-538-14) / 14.1 g in 1 TUBE
NDC 84448-0538-14
🏷️ FDA NDC (as labeled) 84448-538-14 billing pads the product segment with a zero
OTC 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) 84448-538-14
Product NDC 84448-538
11-digit billing NDC 84448053814
RxCUI 346298
UNII O414PZ4LPZ
Application # M006
SPL Set ID 1f92122d-4873-8c1a-e063-6294a90a1c3b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-10-07
Route TOPICAL
Dosage form GEL
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 84448-538-14 — 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 → 84448-0538-14. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerTHG Beauty USA LLC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code84448
First marketedOct 2021
Product typeHuman Otc Drug
Portfolio18 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 it is MedlinePlus · NLM

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or b...

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

Supplement & herbal interactions

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

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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
Walgreens Acne Control Gel 20 mg/mL 00363-0269-83 WALGREEN 1 tube — — FDA listed —
Artistry Studio Done With Zit Acne Treatment Clearing Gel 20 mg/mL 10056-0045-00 Access 1 tube — — FDA listed —
Hero Cosmetics Pimple Correct Salicylic Acid Acne Treatment 20 mg/mL 10237-0003-00 Church 1 tube — — FDA listed —
Acne Treatment Gel 20 mg/mL 31720-0301-08 S+ 1 bottle — — FDA listed —
Eradikate Acne Mark Fading 2 g/100mL 43479-0112-51 KATE 1 bottle — — FDA listed —
Clarifying Peel 2 g/100mL 46007-0102-11 Skin 20 ml — — Discontinued —
ACNE SolutionS CLINICAL ADVANCED CLEARING gel 20 mg/mL 49527-0221-01 CLINIQUE 1 bottle — — Discontinued —
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Cleanser 20 mg/mL 49967-0051-01 L'Oreal 118 ml — — FDA listed —
CeraVe Developed with Dermatologists Acne Control Acne Treatment 20 mg/mL 49967-0172-01 L'Oreal 1 tube — — FDA listed —
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Balm 20 mg/mL 49967-0530-01 L'Oreal 118 ml — — FDA listed —
Vichy Laboratoires Normaderm Phytoaction Acne Control Daily Moisturizer 20 mg/mL 49967-0606-01 L'Oreal 1 bottle — — FDA listed —
Vichy Laboratoires Normaderm Acne Control Daily Moisturizer 20 mg/mL 49967-0660-01 L'Oreal 1 bottle — — FDA listed —
clear days ahead fast-acting salicylic acid acne spot treatment .3 g/15mL 50184-1020-01 Philosophy 15 ml — — FDA listed —
Dr. Dennis Gross Alpha Beta On the Spot Eliminator 20 mg/mL 51326-0057-01 Topiderm, 1 tube — — FDA listed —
GOODBYE ACNE Complete treatment gel .9638 g/48.19g 54031-0069-01 Peter 48.19 g — — FDA listed —
BRODA Acne .4 g/20g 54111-0112-50 Bentley 20 g — — FDA listed —
XtraCare Deep Cleaning Astringent 5 mg/237mg 57337-0035-01 Rejoice 237 mg — — FDA listed —
Acne Defense Spot Treatment Merle Norman 2 g/100g 57627-0201-02 Merle 1 tube — — FDA listed —
Image Clear Cell Acne Spot Treatment 20 g/1000g 60232-5022-01 Swiss-American 14 g — — FDA listed —
Dry It Out Acne Spot Treatment 2 g/100mL 61197-0122-00 Pacifica 29 ml — — FDA listed —
Gm Collin Puracne 20 mg/mL 64127-0195-01 Laboratoires 1 tube — — FDA listed —
Overnight Clearing 20 mg/mL 68479-0706-00 Dermalogica, 2 ml — — FDA listed —
Milani Erase Base Blemish Control Primer 20 mg/mL 68577-0103-00 Cosmax 1 tube — — FDA listed —
PCA SKIN Intensive Clarity Treatment 2 g/100g 68726-0359-02 CP 1 tube — — FDA listed —
PCA Gel 2 g/100mL 68726-0445-02 CP 1 bottle — — FDA listed —
Spot Stopper Acne Spot Treatment 2 g/100mL 69366-0412-32 The 1 tube — — FDA listed —
First Aid Beauty FAB Acne Spot Treatment 2 g/100mL 69423-0724-22 The 1 tube — — FDA listed —
Vichy Laboratoires Normaderm Phytoaction Acne Control Moisturizer 20 mg/mL 69625-0605-01 COSMETIQUE 1 bottle — — FDA listed —
Vichy Laboratoires Normaderm Acne Control Daily Moisturizer 20 mg/mL 69625-0617-01 Cosmetique 1 bottle — — FDA listed —
Vichy Laboratoires Normaderm Acne Control Moisturizer 20 mg/mL 69625-0661-01 COSMETIQUE 1 bottle — — FDA listed —
CVS Health Advanced Acne Spot Treatment 20 mg/mL 69842-0464-52 CVS 1 tube — — FDA listed —
Neutrogena Rapid Clear Acne Eliminating Spot 20 mg/mL 69968-0472-01 Kenvue 1 tube — — FDA listed —
Clean and Clear Acne Spot Treatment 20 mg/mL 69968-0804-01 Kenvue 1 tube — — FDA listed —
Neutrogena Rapid Clear Acne Eliminating Spot 20 mg/mL 69968-0825-01 Kenvue 1 tube — — FDA listed —
Clean and Clear Acne Spot Treatment 20 mg/g 69968-1016-01 Kenvue 1 tube — — FDA listed —
Treat So Deep Acne-Fighting Treatment 2 g/100mL 70626-0106-15 ASPIRE 1 tube — — FDA listed —
Acne Treatment Maximum Strength 2 g/100g 70631-0358-02 Young 1 tube — — FDA listed —
Acne Spot Treatment 2 g/100mL 70764-0105-51 CONTROL 1 bottle — — FDA listed —
innisfree Gentle Retinol Salicylic Acne Serum 1 g/50mL 71220-0088-02 Innisfree 1 tube — — FDA listed —
Peace Out Acne Moisturizer 20 mg/mL 71494-0008-01 Peace 1 jar — — FDA listed —
Acne Gel Pen 20 mg/mL 71714-0004-01 Tiege 1.3 ml — — FDA listed —
Eradikate Acne Mark Fading 2 g/100mL 72204-0903-02 Rare 1 bottle — — FDA listed —
ULTA All Clear SERUM 20 mg/g 79959-0011-01 APR 1 tube — — FDA listed —
The INKEY List C 50 Serum 20 mg/mL 81136-0020-01 Brand 1 bottle — — FDA listed —
The INKEY List Beta Hydroxy Acid Serum 20 mg/mL 81136-0021-01 Brand 1 bottle — — FDA listed —
Vichy Laboratoires Normaderm Acne Control Daily Moisturizer 20 mg/mL 82046-0617-01 LOreal 1 bottle — — FDA listed —
Curology Acne-Clearing Gel Serum 2 g/100mL 82575-0500-00 Curology, 1 tube — — FDA listed —
Good Molecules Maximum Strength Acne Gel Cream 2 g/100mL 82730-0102-01 Good 1 tube — — FDA listed —
Starface Acne Spot Treatment 20 mg/mL 83171-0003-01 Starface 1 tube — — FDA listed —
Dermacleanse Acne Spot Treatment .02 g/mL 83313-0062-01 ZENMED 30 ml — — FDA listed —
Skinkure Acne Eraser Spot Treatment 20 mg/mL 83865-0100-10 SKINKURE, 30 ml — — FDA listed —
Tula Skincare Clear It Up Acne Clearing and Tone Correcting Gel 2 g/100mL 84126-0121-15 The 1 tube — — FDA listed —
SEYTU Spot 2 g/100mL 84271-0002-00 Omnilife 1 tube — — FDA listed —
Perricone MD Acne Relief Maximum Strength Spot Gel 2 g/100gthis 84448-0538-14 THG 1 tube — — FDA listed —
Nativae Milia Acne Serum 20 mg/mL 85065-0557-00 CDE 30 ml — — FDA listed —
TRSTAY LUXE Clarifying Acne Repair Serum .02 g/mL 85277-0001-01 Guangdong 1 bottle — — FDA listed —
Duolaq 20 mg/mL 87110-0001-01 METHODIQ 1 bottle — — FDA listed —
HerbaGlow Baiwooxia Anti-Acne Gel 2 g/100g 87351-0087-01 Kungpo 1 jar — — FDA listed —
The Acne Spot Treatment 2 g/100g 87415-0100-04 Spotless, 1 tube — — FDA listed —
Acne Treatment 2 g/100mL 87799-0999-10 Bio 30 ml — — FDA listed —
Nas Max Strength Spot Treatment 2 g/100g 26052-0022-01 BURT'S 1 tube — — FDA listed —
Salicylic Acid 2 g/100g 71819-0003-04 D3 113 g — — FDA listed —
Asepxia Charcoal Acne Bar 2 g/100g 50066-0801-01 Genomma 1 applicator — — FDA listed —
Asepxia Neutral Acne Bar 2 g/100g 50066-0802-01 Genomma 1 applicator — — FDA listed —
Asepxia Oil-Free Acne Bar 2 g/100g 50066-0803-01 Genomma 1 applicator — — FDA listed —
Asepxia Scrub Acne Bar 2 g/100g 50066-0804-01 Genomma 1 applicator — — FDA listed —
Asepxia Softening Acne Bar 2 g/100g 50066-0805-01 Genomma 1 applicator — — FDA listed —
Tingl Exfoliating Pads 2 g/100g 83286-0011-01 Drmtlgy, 60 patches — — FDA listed —
Alba Natural Acnedote Astringent 2 g/100g 61995-2753-06 The 177 g — — FDA listed —
Clear Proof Clarifying Cleansing Gel Acne Medication 2 g/100g 51531-1349-01 Mary 28 g — — FDA listed —
Spot Acne Treatment Oil Free 0.75oz 2 g/100g 57337-0168-01 Rejoice 21 g — — FDA listed —
Blemish Control Bar 2 g/100g 68726-0439-01 CP 1 jar — — FDA listed —
AL00761 Alba Botanica Acnedote Face and Body Scrub 2 g/100g 61995-3761-09 The 227 g — — FDA listed —
Acne Warrior Body Scrub 2 g/100g 61197-0410-00 Pacifica 170 g — — FDA listed —
Zapzyt Acne Wash Cleanser 2 g/100g 71687-0007-01 Focus 188.5 g — — FDA listed —
Proven Acne Cleanser 2 g/100g 73572-0011-01 Proven 50 g — — FDA listed —
Kenkoderm Psoriasis Moisturizing 2 g/100g 85286-0004-01 Nexgel,Inc. 295 g — — FDA listed —
Clarifying Cleanser 2 g/100g 72957-0011-01 Private 203 g — — FDA listed —
Proven Acne Cleanser 2 g/100g 73572-0010-01 Proven 50 g — — FDA listed —
Tagrid Tinea Versicolor 2 g/100g 85384-0016-01 TAGRID 95.83 g — — FDA listed —
Advanced DermaClear Serum 2 g/100g 62742-4280-02 Allure 1 bottle — — FDA listed —
Shaant Hydrating Body Scrub 2 g/100g 83196-0785-12 Codex 1 tube — — FDA listed —
Kenkoderm Psoriasis Moisturizing 2 g/100g 73632-0004-01 Olympus 295 g — — FDA listed —
Shaant Pore Purifying Face Scrub 2 g/100g 83196-0676-12 Codex 1 tube — — FDA listed —
ES Salicylic Wash 2 g/100g 87702-0141-01 Elaine 200 g — — FDA listed —
AL0076001 Alba Botanica Acnedote Deep Pore Wash 2 g/100g 61995-2060-06 The 177 g — — FDA listed —
Soraresal 2 g/100g 73526-0002-02 Summer 1 bottle — — FDA listed —
Orlaskin Salicylic Acid Acne Treatment Pads 2 g/100g 87582-0006-01 Guangzhou 80 patches — — FDA listed —
PCA Skin Acne Control Prebiotic Cleanser 2 g/100g 68726-0607-02 CP 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

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 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.

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

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

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Perricone MD Acne Relief Maximum Strength Spot Gel (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Age at onset

Neonate7
Infant1
Child8
Adolescent5
Adult170
Elderly94

Reporter sex

1,852 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization622
Death611
Life-threatening174
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 243 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
84448-0538-14 You're viewing this 1 TUBE in 1 CARTON (84448-538-14) / 14.1 g in 1 TUBE 2021-10-07 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) — 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

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 84448-538-14, 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: 84448-0538-14, written without dashes as 84448053814. 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 84448-0538-14, the first segment (84448) is the labeler code FDA assigned to THG Beauty USA LLC; the middle segment (0538) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (14) 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 THG Beauty USA LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
THG Beauty USA 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 5 words ▾

For the treatment of acne

⏱️ Dosage and Administration 99 words ▾

Directions Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Sensitivity Test for a New User Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

⚠️ Warnings 4 words ▾

For external use only.

🧪 Active Ingredient 3 words ▾

Salicylic Acid 2%

🧪 Inactive Ingredients 35 words ▾

Water/Aqua/Eau, SD Alcohol 40-B, Propanediol, Hamamelis Virginiana (Witch Hazel) Water, Glycerin, Citrulline, Sucrose, Hydroxyethylcellulose, Urea, Alcohol, Polysorbate 20, Panthenol, Sodium Hydroxide, Succinic Acid, Lactic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tetrasodium Glutamate Diacetate, Limonene

🎯 Purpose 2 words ▾

Acne Treatment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84448-0537-21 · THG 84448-0539-17 · THG →
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.