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Tula Skincare Breakout Star Lightweight Acne Moisturizer Salicylic Acid 2 g/100mL Cream, 15 mL — NDC 84126-0229-15 package photo

Tula Skincare Breakout Star Lightweight Acne Moisturizer Salicylic Acid 2 g/100mL Cream, 15 mL

by The Procter & Gamble Manufacturing Company · 15 mL in 1 TUBE (84126-229-15)
NDC 84126-0229-15
🏷️ FDA NDC (as labeled) 84126-229-15 billing pads the product segment with a zero
This package
Contains15 mL Pack sizes2 compare ↓
Also comes in: 50 ml 84126-0229-51
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) 84126-229-15
Product NDC 84126-229
11-digit billing NDC 84126022915
RxCUI 317152
UNII O414PZ4LPZ
Application # M006
SPL Set ID 4bd1d5f5-1b3c-5e82-e063-6394a90a6454
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-01
Route TOPICAL
Dosage form CREAM
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 84126-229-15 — 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 → 84126-0229-15. 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

LabelerThe Procter & Gamble Manufacturing Company
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code84126
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio849 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

📗 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.
Try another pack size: 50 ml
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
Anew Bare Acne Clearing Treatment 2% Salicylic Acid 20 mg/mL 10096-2932-01 THE 1 tube — — FDA listed —
Proactiv Plus Retexturizing Toner 20 mg/mL 11410-0051-00 Alchemee, 1 bottle — — FDA listed —
Nas Max Strength Spot Treatment 2 g/100g 26052-0022-01 BURT'S 1 tube — — FDA listed —
CeraVe Developed with Dermatologists Psoriasis Moisturizing 20 mg/g 49967-0701-01 L'Oreal 227 g — — FDA listed —
Asepxia Acne Treatment 20 mg/g 50066-0064-01 Genomma 1 tube — — FDA listed —
Clear Exfoliating Solution Paulas Choice 2 g/100mL 56152-5002-01 Cosmetic 118 ml — — FDA listed —
Spot Acne Treatment Oil Free 0.75oz 2 g/100g 57337-0168-01 Rejoice 21 g — — FDA listed —
Spot Acne Treatment Oil Free 0.75oz 2 g/100g 58503-0204-01 China 21 g — — FDA listed —
Atrix Acne Treatment 20 mg/mL 59088-0446-05 PureTek 59 ml — — FDA listed —
Acne Spot Treatment 2% Bha 2 g/100mL 61328-0404-05 Skinfix, 15 ml — — FDA listed —
DermaClear Serum 20 mg/mL 62742-4069-02 Allure 1 tube — — FDA listed —
Dermaclear Mask 20 mg/g 62742-4074-02 Allure 1 tube — — FDA listed —
Advanced DermaClear Serum 2 g/100g 62742-4280-02 Allure 1 bottle — — FDA listed —
Natureplex Psoriasis 20 mg/g 67234-0073-01 Natureplex, 1 tube — — FDA listed —
Alumier MD Acne Balancing Serum 20 mg/mL 69473-0002-01 Alumier 1 bottle — — FDA listed —
DermaD ATOPIC DERMATITIS Therapeutic 20 mg/g 70794-0101-28 Chen 81 g — — FDA listed —
DermaD JOCK ITCH Therapeutic 20 mg/g 70794-0201-82 Chen 81 g — — FDA listed —
DermaD Psoriasis Therapeutic 20 mg/g 70794-0261-25 Chen 81 g — — FDA listed —
DermaD ANTI-ITCH Therapeutic 20 mg/g 70794-0313-94 Chen 81 g — — FDA listed —
DermaD ANTIFUNGAL Therapeutic 20 mg/g 70794-0708-85 Chen 81 g — — FDA listed —
MILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic Acid 20 mg/mL 71435-0005-00 New 30 ml — — FDA listed —
Tiege Hanley 20 mg/mL 71714-0003-24 Tiege 24 ml — — FDA listed —
MDacne Customized Acne Treatment Salicylic Acid 20 mg/mL 71804-0533-00 MDAlgorithms 1 tube — — FDA listed —
Soraresal 2 g/100g 73526-0002-02 Summer 1 bottle — — FDA listed —
Kenkoderm Psoriasis Moisturizing 2 g/100g 73632-0004-01 Olympus 295 g — — FDA listed —
ELF Blemish Control Face Primer Clear 2 g/100mL 76354-0210-10 e.l.f. 30 ml — — FDA listed —
ELF Clear Blemish Control Face Primer 2 g/100mL 76354-0624-01 e.l.f. 14 ml — — FDA listed —
Therapeutic Hydrogel 1 g/50g 78863-1090-01 Noon 1 bottle — — FDA listed —
Equate 20 mg/mL 79903-0317-68 Walmart 200 ml — — FDA listed —
VANIBISS BUTT and THIGHS Acne Treatment Cream 20 mg/mL 81890-0192-00 Vanibiss 1 jar — — FDA listed —
SIMPLY VITAL Acne Face Cream 20 mg/mL 82460-0272-00 ALPHA 60 ml — — FDA listed —
Acne Toner Serum 2 g/100mL 82870-0003-01 Dime 60 ml — — FDA listed —
Acne Spot Treatment 2 g/100mL 82870-0006-01 Dime 15 ml — — FDA listed —
Pureskin Seborrheic Dermatitis Psoriasis Cream 2 g/100mL 83887-0007-01 Changsha 100 ml — — Discontinued —
Tula Skincare Breakout Star Lightweight Acne Moisturizer 2 g/100mLthis 84126-0229-15 The 15 ml — — FDA listed —
Acne Treatment Cream 2 g/100mL 84356-0006-01 Guangzhou 50 ml — — FDA listed —
Perricone MD Acne Relief Maximum Strength Clearing Treatment 2 g/100mL 84448-0301-59 THG 1 bottle — — FDA listed —
Kenkoderm Psoriasis Moisturizing 2 g/100g 85286-0004-01 Nexgel,Inc. 295 g — — FDA listed —
Cleansing Wipes 2 g/100mL 71613-0001-01 Nextcell 25 applicators — — FDA listed —
Oxygenetix Oxygenating Foundation Acne Control 2 g/100mL 10258-0101-11 COLONIAL 15 ml — — Discontinued —
Spot Stopper Acne Spot Treatment 2 g/100mL 69366-0412-32 The 1 tube — — FDA listed —
Pert 2 in 1 Advanced plus 2 g/100mL 81277-0802-13 Sodalis 400 ml — — FDA listed —
Eradikate Acne Mark Fading 2 g/100mL 43479-0112-51 KATE 1 bottle — — FDA listed —
Acne Control Face Wash 2 g/100mL 54111-0185-01 Bentley 180 ml — — FDA listed —
Salicylic Wash 2 g/100mL 70764-0102-56 CONTROL 1 bottle — — FDA listed —
Acne Spot Treatment 2 g/100mL 70764-0105-51 CONTROL 1 bottle — — FDA listed —
Acne Correction Pads 2 g/100mL 72957-0012-01 Private 1 jar — — FDA listed —
Multi-Action Clear - Acne Clearing Treatment 2% Salicylic Acid 2 g/100mL 76147-0301-07 StriVectin 1 tube — — FDA listed —
PanOxyl Acne Gel Wash 2 g/100mL 00316-0299-01 Crown 192 ml — — FDA listed —
PCA Gel 2 g/100mL 68726-0445-02 CP 1 bottle — — FDA listed —
First Aid Beauty FAB Acne Spot Treatment 2 g/100mL 69423-0724-22 The 1 tube — — FDA listed —
SEYTU Spot 2 g/100mL 84271-0002-00 Omnilife 1 tube — — FDA listed —
Pharma Clear Cleanser 2 g/100mL 67879-0101-11 PHARMAGEL 175 ml — — FDA listed —
Start So Fresh 2 g/100mL 70626-0105-13 ASPIRE 100 ml — — FDA listed —
Treat So Deep Acne-Fighting Treatment 2 g/100mL 70626-0106-15 ASPIRE 1 tube — — FDA listed —
Good Molecules Acne Foaming Cleanser 2 g/100mL 82730-0100-05 Good 148 ml — — FDA listed —
Acne Control Superclean Body Wash AHA BHA Formula 2 g/100mL 54111-0170-50 Bentley 250 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 —
Perricone MD Acne Relief Gentle and Soothing Cleanser 2 g/100mL 84448-0539-17 THG 1 tube — — FDA listed —
Clearasil Stubborn Acne Control 5in1 Exfoliating Wash 2 g/100mL 63824-0436-01 Reckitt 200 ml — — FDA listed —
Curology Acne-Clearing Gel Serum 2 g/100mL 82575-0500-00 Curology, 1 tube — — FDA listed —
First Aid Beauty Acne Clearing Pads 2 g/100mL 84126-0119-60 The 60 patches — — FDA listed —
Perricone MD Acne Relief Calming and Soothing Clay Mask 2 g/100mL 84448-0955-10 THG 10 ml — — FDA listed —
Proactiv Deep Cleansing Wash 2 g/100mL 11410-0048-05 THE 1 bottle — — FDA listed —
Good Molecules Acne Foaming Cleanser 2 g/100mL 64412-1005-02 Twincraft 1 bottle — — FDA listed —
Ultra Clear Treatment 2 g/100mL 10028-0051-01 ULTRACEUTICALS 50 ml — — FDA listed —
Clear System Clarifying Gel Cleanser 2 g/100mL 54111-0189-20 Bentley 20 ml — — FDA listed —
anna lotan PURIFYING PADS with 2% Salicylic Acid 2 g/100mL 76446-0039-50 Anna 1 jar — — Discontinued —
Clarifying Peel 2 g/100mL 46007-0102-11 Skin 20 ml — — Discontinued —
Acne Control Body Wash 2 g/100mL 54111-0184-01 Bentley 250 ml — — FDA listed —
Bha Cleanser 2% 2 g/100mL 61328-0403-01 Skinfix, 30 ml — — FDA listed —
Eradikate Acne Mark Fading 2 g/100mL 72204-0903-02 Rare 1 bottle — — FDA listed —
Triderma Psoriasis Control Body Wash 2 g/100mL 10738-0217-63 Genuine 473 ml — — FDA listed —
Proactivplus Pore Clearing Treatment 2 g/100mL 11410-0047-30 Alchemee, 1 tube — — FDA listed —
First Aid Beauty FAB Pharma White Clay Acne Treatment 2 g/100mL 69423-0555-60 The 60 patches — — FDA listed —
ESSENCE BY CATHERINE HINDS PURIFYING PADS with 2% Salicylic Acid 2 g/100mL 76446-0022-50 Anna 1 jar — — FDA listed —
Good Molecules Maximum Strength Acne Gel Cream 2 g/100mL 82730-0102-01 Good 1 tube — — FDA listed —
Dry It Out Acne Spot Treatment 2 g/100mL 61197-0122-00 Pacifica 29 ml — — FDA listed —
Clearasil Rapid Rescue Deep Treatment Wash 2 g/100mL 63824-0432-01 Reckitt 200 ml — — FDA listed —
Good Molecule Maximum Strenght Acne 2 g/100mL 68577-0287-00 COSMAX 1 tube — — FDA listed —
ORLASKIN ACNE Treatment 2 g/100mL 87582-0005-01 Guangzhou 50 ml — — FDA listed —
SUZANOBAGIMD Acne Cleansing Wipes 2 g/100mL 62032-0617-25 Obagi 25 patches — — FDA listed —
Bliss Care Acne Treatment Gel 2 g/100mL 83566-0627-01 Guangdong 10 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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 Tula Skincare Breakout Star Lightweight Acne Moisturizer (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

1,853 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization623
Disabling124
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 154 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
84126-0229-15 You're viewing this 15 mL in 1 TUBE (84126-229-15) 2025-06-01 Active
84126-0229-51 50 mL in 1 BOTTLE, PUMP (84126-229-51) 2025-06-01 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 84126-0229-15?
NDC 84126-0229-15 contains 15 mL — 15 ml in 1 tube.
What is the difference between NDC 84126-0229-15 and NDC 84126-0229-51?
Both are Tula Skincare Breakout Star Lightweight Acne Moisturizer Salicylic Acid 2 g/100mL Cream — the drug itself is identical. NDC 84126-0229-15 is the 15 mL package, while NDC 84126-0229-51 is the 50 ml package.
What NDC number is used to bill for this package of Tula Skincare Breakout Star Lightweight Acne Moisturizer Salicylic Acid 2 g/100mL Cream?
Bill NDC 84126-0229-15 — the 11-digit billing format is 84126022915. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ 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

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 84126-229-15, 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: 84126-0229-15, written without dashes as 84126022915. 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 84126-0229-15, the first segment (84126) is the labeler code FDA assigned to The Procter & Gamble Manufacturing Company; the middle segment (0229) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) 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 The Procter & Gamble Manufacturing Company. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 50 ml (84126-0229-51). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
The Procter & Gamble Manufacturing Company 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 ▾

Uses For treatment of acne

⏱️ Dosage and Administration 69 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 uses 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.

⚠️ Warnings 88 words ▾

For external use only When using this product Apply only to areas with acne Avoid contact with the eyes If contact occurs, rinse thoroughly with water Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if skin irritation occurs/gets worse.

🧪 Active Ingredient 5 words ▾

Active ingredients Salicylic Acid 2%

🧪 Inactive Ingredients 85 words ▾

WATER, PROPANEDIOL, DIMETHICONE, GLYCERIN, DIMETHYL ISOSORBIDE, LACTOCOCCUS FERMENT LYSATE, POLYSORBATE 20, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, NIACINAMIDE, ALOE BARBADENSIS LEAF JUICE, AZELAIC ACID, BISABOLOL, CETEARYL OLIVATE, CITRULLUS LANATUS (WATERMELON) FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) PEEL EXTRACT, EPILOBIUM ANGUSTIFOLIUM FLOWER/LEAF/STEM EXTRACT, LACTIC ACID, LENS ESCULENTA (LENTIL) FRUIT EXTRACT, OCIMUM SANCTUM LEAF EXTRACT, OZONIZED ORYZA SATIVA (RICE) CALLUS CULTURE EXTRACT, PHENOXYETHANOL, POLYACRYLATE CROSSPOLYMER-6, SACCHARIDE ISOMERATE, SODIUM CHLORIDE, SODIUM LACTATE, SODIUM PCA, SORBITAN ISOSTEARATE, SORBITAN OLIVATE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, ETHYLHEXYLGLYCERIN, XANTHAN GUM

🎯 Purpose 3 words ▾

Purpose Acne Treatment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84126-0228-73 · The 84126-0231-12 · The →
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.