NDC 42192-0151-01 — HYDROQUINONE 4% 40 mg/g Cream, 1 tube

🆔 Identity & classification

FDA NDC (as labeled) 42192-151-01

Product NDC 42192-151

11-digit billing NDC 42192015101

NCPDP billing unit GM — per gram (weight)

RxCUI 197795

UNII XV74C1N1AE

SPL Set ID 595dfc50-ee6f-41b5-ab5b-4c293aee342b

Established class (EPC) Melanin Synthesis Inhibitor

Mechanism of action Melanin Synthesis Inhibitors

Physiologic effect Depigmenting Activity

DEA schedule Non-controlled

Marketing category UNAPPROVED DRUG OTHER

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2014-09-10

Route TOPICAL

Dosage form CREAM

Substance HYDROQUINONE

GCN Seq No 006313

GCN 24883

HICL code 002721

Ingredient (HICL) Hydroquinone

HIC1 code L

Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue

HIC2 code L9

Therapeutic class — intermediate (HIC2) Dermatologic Preparations,Miscellaneous

HIC3 code L9C

Therapeutic class — specific (HIC3) Hypopigmentation Agents

AHFS code 84:50.04.00

AHFS class Depigmenting Agents

FDB label name HYDROQUINONE 4% CREAM

FDB brand name Hydroquinone

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 42192-151-01 — 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 → 42192-0151-01. 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 Melanin Synthesis Inhibitor class.

Pharmacologic class Melanin Synthesis Inhibitor

Drug family (ATC) Other dermatologicals

How it works Melanin Synthesis Inhibitors

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

LabelerAcella Pharmaceuticals, LLC

Labeler code42192

First marketedSep 2014

Product typeHuman Prescription Drug

Portfolio36 products on file

🔎 All NDCs from Acella Pharmaceuticals, LLC

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 HYDROQUINONE 4% CREAM Ingredient Hydroquinone

🧪 What is this product?

This is a topical cream containing hydroquinone 4% (40 mg per gram). Hydroquinone is a melanin synthesis inhibitor typically used in skin-lightening products to reduce the appearance of dark spots, uneven skin tone, and hyperpigmentation on the face and body. This product is marketed without an approved FDA application and should only be used under the direction of a healthcare provider.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
UNII E4F12ROE70
A refined mineral oil derived from crude petroleum containing 13 to 14 carbon chains. It acts as a solvent, emollient, and carrier in topical formulations to help dissolve active ingredients and improve product texture and spreadability.
UNII 8TY5YO42NJ
Capryloyl glycine is a mild, skin-conditioning ingredient made from a natural fatty acid and the amino acid glycine. In medicines, it acts as a surfactant and preservative booster, helping the product spread evenly and resist contamination.
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 0WT12SX38S
Glycolic acid is an alpha-hydroxy acid derived from sugar cane that helps dissolve and remove dead skin cells. In topical medicines, it works as an exfoliant and pH adjuster to improve skin penetration and product effectiveness.
UNII 724GKU717M
Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
UNII 6K23F1TT52
Kojic acid is a naturally derived compound used as a preservative and antioxidant in medicines. It helps prevent spoilage and maintain product stability during storage.
UNII Z95S6G8201
A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
UNII 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
UNII RHA9LWJ494
A synthetic polymer formed by linking acrylamide molecules together. It functions as a binder and thickener in medicines, helping hold ingredients together and adjust the product's texture and consistency.
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 GW89575KF9
Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
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.
UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

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 system	Per g	Per package
Retail pharmacies payNADAC · weekly	$0.513	$14.54 / 28.35 g
Medicaid paysCMS SDUD · 12 mo	$1.00	$28.37 / 28.35 g
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

NADAC price history (per g) — tap or hover for the price & month

▼ Down 53% over the last 24 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Hydroquinone 4% 40 mg/g 75834-0137-01	Nivagen	1 tube	$0.461	—	Availability likely	save 10%
Hydroquinone 4% 40 mg/gthis 42192-0151-01	Acella	1 tube	$0.513	—	Availability likely	—
Hydroquinone 40 mg/g 69367-0174-01	Westminster	1 tube	$0.513	—	Availability likely	—
hydroquinone 40 mg/g 10135-0724-99	Marlex	1 tube	—	—	FDA listed	—
Hydroquinone cream 40 mg/g 24689-0101-01	APNAR	1 tube	—	—	FDA listed	—
Hydroquinone 4% 40 mg/g 50405-0800-01	SOHM,	1 tube	—	—	FDA listed	—
NU-DERM BLENDER Skin Lightener and Blending 40 mg/g 62032-0100-10	Obagi	28 g	—	—	FDA listed	—
NU-DERM CLEAR Skin Bleaching and Corrector 40 mg/g 62032-0101-36	Obagi	57 g	—	—	FDA listed	—
Obagi-C Rx system C-Therapy Night Skin Lightening with Vitamins C and E 40 mg/g 62032-0105-36	Obagi	57 g	—	—	FDA listed	—
NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE 40 mg/g; 75 mg/g; 55 mg/g 62032-0116-36	Obagi	57 g	—	—	FDA listed	—
Hydroquinone 4% 40 mg/g 71399-0400-01	Akron	28.35 g	—	—	FDA listed	—
Hydroquinone 4% 40 mg/g 72162-2422-02	Bryant	1 tube	—	—	FDA listed	—
Hydro-Q 40 mg/g 30815-0040-01	Dermavance	1 tube	—	—	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

🏛️

2014

On the market since

Sep 2014

📍

2026

Currently FDA-listed

12 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 42192-0151-01, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

1.8K

Units reimbursed last 4 qtrs

55.3K

Gross reimbursed last 4 qtrs

$55.3K

Avg / prescription

$30.02

Avg / unit

$1.0006

Latest quarter Q4 2025

449Rx

Medicaid pays / g

$1.0006

gross reimbursed

vs

NADAC / g

$0.5130

acquisition cost

=

Spread

+$0.4876

+95% vs cost

What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

46% FFS 54% MCO

Fee-for-service · 847 Rx Managed care · 995 Rx

State Medicaid map

Units reimbursed · per 100k residents

2.1633

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Connecticut 633 /100k

2 Kentucky 266 /100k

3 Alaska 263 /100k

4 Indiana 66.9 /100k

5 Ohio 53.4 /100k

6 South Dakota 33.9 /100k

7 Michigan 31.1 /100k

8 Illinois 16.9 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 Hydroquinone — the ingredient across all brands.

Top reported reactions

Erythema177

Condition Aggravated104

Skin Burning Sensation100

Pruritus87

Skin Exfoliation82

Dry Skin68

Rash66

Age at onset

Adolescent1

Adult94

Elderly26

Reporter sex

Male · 11%

Female · 89%

Unknown · 0%

Serious outcomes

Hospitalization109

Disabling22

Death19

Life-threatening11

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
42192-0151-01 You're viewing this	1 TUBE in 1 CARTON (42192-151-01) / 28.35 g in 1 TUBE	2014-09-10	Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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)	✓ Available
NADAC pharmacy acquisition price (CMS)	✓ Available
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)	✓ Available

“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 "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.

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 42192-151-01, 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: 42192-0151-01, written without dashes as 42192015101. 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 42192-0151-01, the first segment (42192) is the labeler code FDA assigned to Acella Pharmaceuticals, LLC; the middle segment (0151) 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 Acella Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Acella Pharmaceuticals, 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 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 30 words ▾

INDICATIONS AND USAGE HYDROQUINONE 4% CREAM is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

⏱️ Dosage and Administration 74 words ▾

DOSAGE AND ADMINISTRATION Completely remove the foil seal. HYDROQUINONE 4% CREAM should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. If no improvement is seen after 2 months of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.

⛔ Contraindications 38 words ▾

CONTRAINDICATIONS Prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product. The safety of topical hydroquinone use during pregnancy or for children (12 years and under) has not been established.

⚠️ Warnings 79 words ▾

WARNINGS Since this product contains no sunscreen, an effective broad spectrum sun blocking agent should be used and unnecessary solar exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring. Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician.

The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics.

🤒 Adverse Reactions 40 words ▾

ADVERSE REACTIONS The following adverse reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued and the physician notified immediately.

🔄 Drug Interactions 17 words ▾

Drug Interactions - Patients are cautioned on concomitant use of medications that are known to be photosensitizing.

🤰 Pregnancy 103 words ▾

Pregnancy: Teratogenic Effects: Pregnancy Category C - Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed.

Pregnancy Category C - Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 19 words ▾

Pediatric Use - Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

🆘 Overdosage 47 words ▾

OVERDOSAGE There have been no systemic reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

🧬 Clinical Pharmacology 58 words ▾

CLINICAL PHARMACOLOGY Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (dopa) (Denton, C. et al., 1952)1 and suppression of other melanocyte metabolic processes (Jimbow, K. et al., 1974)2. Exposure to sunlight or ultraviolet light will cause repigmentation of bleached areas (Parrish, L.A. et al., 1978)3.

📦 How Supplied / Storage and Handling 39 words ▾

HOW SUPPLIED HYDROQUINONE 4% CREAM is available in a 1 oz (28.35 g) tube with (NDC 42192-151-01) Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]

📦 Storage and Handling 22 words ▾

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]

📋 Description 69 words ▾

DESCRIPTION Each gram of HYDROQUINONE 4% CREAM contains 40 mg hydroquinone, in a tan-colored cream base of Alcohol, Capryloyl Glycine, C13-14 Isoparaffin, Glycerin, Glycolic Acid, Kojic Acid, Laureth-7, Lecithin, Polyacrylamide, Purified Waters, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Squalane and Xanthan Gum. Chemically, hydroquinone is C6H6O2 and has a molecular weight of 110.11. The chemical name is 1,4 dihydroxybenzene, and the structural formula of hydroquinone is: Chemical Structure

💬 Information for Patients 84 words ▾

Information for Patients - Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity. To prevent repigmentation, during treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of a broad spectrum sunscreen (SPF 15 or greater) or by use of protective clothing. Avoid contact with eyes and mucous membranes.

Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

Glossary — plain-language definitions of medical terms used in this label:

photosensitizing: Making the skin more likely to burn or react in sunlight.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

contact dermatitis: A skin rash caused by touching something that irritates the skin or triggers an allergy.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

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

🔗 Related NDC lookups

🧪 All Hydroquinone NDCsSame ingredient 🏭 All Acella labeler NDCsLabeler code 42192 📚 All Melanin Synthesis Inhibitor NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Hypopigmentation Agents.

Fluocinolone/Tretinoin/H-Quin 00299-5950-02 Hydroquinone/Vit C/Vit E Acet 62032-0105-36 Hydroquinone/Ascorbic Acid 62032-0106-10 Hydroquinone/Oxyben/Octinoxate 62032-0116-36

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.