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metronidazole 10 mg/g Gel, 55 g

by Prasco Laboratories · 55 g in 1 BOTTLE, PUMP (66993-936-58)
NDC 66993-0936-58
🏷️ FDA NDC (as labeled) 66993-936-58 billing pads the product segment with a zero
This package
Contains55 g Cost per g$0.8659 NADAC Per package$47.62 / 55 g Pack sizes2 compare ↓
Also comes in: 60 g 66993-0936-61
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 2, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 66993-936-58
Product NDC 66993-936
11-digit billing NDC 66993093658
NCPDP billing unit GM — per gram (weight)
RxCUI 577237
UNII 140QMO216E
Application # NDA021789
SPL Set ID 7c35a751-58ca-4186-91a0-7c11d49144c4
Established class (EPC) Nitroimidazole Antimicrobial
Chemical class Nitroimidazoles
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jun 2026)
Marketing start 2005-06-30
Marketing end 2026-06-30
Route TOPICAL
Dosage form GEL
Substance METRONIDAZOLE
GPI-14 90060040004020
GPI class metroNIDAZOLE
GCN Seq No 068879
GCN 31774
HICL code 004157
Ingredient (HICL) Metronidazole
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5G
Therapeutic class — specific (HIC3) Rosacea Agents, Topical
AHFS code 08:30.04.00
AHFS class Amebicides
FDB label name METRONIDAZOLE TOP 1% GEL PUMP
FDB brand name Metronidazole
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 66993-936-58 — 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 → 66993-0936-58. 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 Nitroimidazole Antimicrobial class.

Pharmacologic class Nitroimidazole Antimicrobial
Drug family (ATC) Nitroimidazole derivatives, Antiinfectives and antiseptics for local oral treatment, Other chemotherapeutics
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

LabelerPrasco Laboratories
Application holderGALDERMA LABORATORIES LP
FDA applicationNDA021789 (NDA AUTHORIZED GENERIC)
Labeler code66993
First marketedJun 2005
Product typeHuman Prescription Drug
Portfolio106 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

Label name METRONIDAZOLE TOP 1% GEL PUMP Ingredient Metronidazole
📗 Our plain-language guide HelloPharmacist
  • This is one of the most important things to know about metronidazole. If you drink alcohol — or consume products containing propylene glycol — while taking it, you can have a prett...
  • Why do I have to avoid alcohol while taking this?
  • Yes, completely normal and actually really important. Trichomoniasis is a sexually transmitted infection, so even if your partner has no symptoms, they can still carry the parasite...
  • My partner and I both have to take this for trichomoniasis — is that normal?
📖 Read our full Metronidazole guide →
7
Nutrient depletion considerations

Metronidazole may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Metronidazole nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 $0.866 $47.62 / 55 g
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 g) — tap or hover for the price & month
Dec 2021 Mar 2022 Jul 2022 Nov 2022 $1.227 $0.687
▼ Down 9% over the last 10 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metronidazole 10 mg/g 68308-0663-55 Mayne 1 bottle $0.565 AB Availability likely save 35%
Metronidazole 10 mg/g 00713-0574-60 Cosette 1 tube $0.621 AB Availability likely save 28%
Metronidazole 10 mg/g 51672-4215-03 Sun 1 tube $0.621 AB Availability likely save 28%
Metronidazole 10 mg/g 59651-0813-60 Aurobindo 1 tube $0.621 AB Availability likely save 28%
Metronidazole 10 mg/g 51672-4164-03 Sun 1 tube $0.672 AB Discontinued save 22%
metronidazole 10 mg/gthis 66993-0936-58 Prasco 55 g $0.866 AB Discontinued —
Metronidazole 10 mg/g 46708-0630-45 Alembic 1 tube — AB FDA listed —
Metronidazole 10 mg/g 62332-0630-45 Alembic 1 tube — AB FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
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

🏛️
2005
On the market since
Jun 2005
📍
2026
Currently FDA-listed
21 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
60 gs66993-0936-61 76 Rx · $5,579
55 gs this page66993-0936-58 No Medicaid data
Drug total (last 4 qtrs): 76 Rx · 5,280 units · $5,579 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Metronidazole — the program that covers self-administered drugs. 23 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 Metronidazole. 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
$12.08M
Claims incl. refills
571.7K
Beneficiaries
500.3K
Spend / beneficiary
$24.15
Spend / claim
$21.13
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 Metronidazole — the ingredient across all brands.

Top reported reactions

Nausea4,812
Diarrhoea4,197
Vomiting3,393
Pyrexia3,294
Drug Hypersensitivity3,160
Pain3,080
Abdominal Pain3,057

Age at onset

Neonate223
Infant82
Child252
Adolescent271
Adult5,483
Elderly2,552

Reporter sex

64,630 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization27,458
Death6,867
Life-threatening5,251
Disabling2,508
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,750 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 Per unit Per pack Marketing startStatus
66993-0936-58 You're viewing this 55 g in 1 BOTTLE, PUMP (66993-936-58) $0.8659 / g $47.63 2017-02-02 Discontinued by firm
66993-0936-61 60 g in 1 TUBE (66993-936-61) $0.6209 / g $37.26 2017-02-02 Discontinued by firm

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

Per g, this pack runs about 39% above the cheapest pack (60 g, $0.6209 vs $0.8659 NADAC).

Pack size FAQ

What quantity is in NDC 66993-0936-58?
NDC 66993-0936-58 contains 55 g — 55 g in 1 bottle, pump.
What is the difference between NDC 66993-0936-58 and NDC 66993-0936-61?
Both are metronidazole 10 mg/g Gel — the drug itself is identical. NDC 66993-0936-58 is the 55 g package, while NDC 66993-0936-61 is the 60 g package. Per-g NADAC also differs: $0.8659 here vs $0.6209 for the 60 g pack.
What NDC number is used to bill for this package of metronidazole 10 mg/g Gel?
Bill NDC 66993-0936-58 — the 11-digit billing format is 66993093658. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 66993-936-58, 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: 66993-0936-58, written without dashes as 66993093658. 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 66993-0936-58, the first segment (66993) is the labeler code FDA assigned to Prasco Laboratories; the middle segment (0936) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (58) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 60 g (66993-0936-61). 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?
Prasco Laboratories 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Patient Medication Information
🎯 Indications and Usage 37 words ▾

1 INDICATIONS AND USAGE Metronidazole Gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. Metronidazole Gel, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. ( 1 )

⏱️ Dosage and Administration 108 words ▾

2 DOSAGE AND ADMINISTRATION Cleanse treated areas before the application of Metronidazole Gel, 1%. Apply and rub in a thin film of Metronidazole Gel, 1% once daily to affected area(s). Cosmetics may be applied after the application of Metronidazole Gel, 1%.

For topical use only, not for oral, ophthalmic, or intravaginal use. Cleanse treated areas before the application of Metronidazole Gel, 1% ( 2 ) Apply and rub in a thin film of Metronidazole Gel, 1% once daily to affected area(s). ( 2 ) Cosmetics may be applied after the application of Metronidazole Gel, 1%.

( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )

💊 Dosage Forms and Strengths 34 words ▾

3 DOSAGE FORMS AND STRENGTHS Gel, 1%. Metronidazole Gel,1% is a clear, colorless to pale yellow gel. Each gram of Metronidazole Gel, 1% contains 10 mg (1%) of metronidazole. Gel, 1%. ( 3 )

⛔ Contraindications 50 words ▾

4 CONTRAINDICATIONS Metronidazole Gel, 1% is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation. Metronidazole Gel, 1% is contraindicated in those patients with a history of hypersensitivity to metronidazole or to any other ingredient in this formulation. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Neurologic Disease : Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Peripheral neuropathy has been reported with the post approval use of topical metronidazole. Immediately reevaluate Metronidazole Gel therapy if abnormal neurologic signs appear.

( 5.1 ) Blood Dyscrasias : Metronidazole Gel, 1% is a nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia. ( 5.2 ) Contact Dermatitis: If dermatitis occurs, patients may need to discontinue use. ( 5.3 ) Eye Irritation: Topical metronidazole has been reported to cause tearing of the eyes.

Avoid contact with the eyes. ( 5.4 )

5.1Neurologic Disease Peripheral neuropathy, characterized by numbness or paresthesia of an extremity, has been reported in patients treated with systemic metronidazole. Peripheral neuropathy has been reported with the post approval use of topical metronidazole. Immediately reevaluate Metronidazole Gel, 1% therapy if abnormal neurological signs appear. Administer metronidazole with caution to patients with central nervous system diseases.

5.2Blood Dyscrasias Metronidazole is a nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia.

5.3Contact Dermatitis Irritant and allergic contact dermatitis have been reported with Metronidazole Gel, 1%. If dermatitis occurs, patients may need to discontinue use.

5.4Eye Irritation Topical metronidazole has been reported to cause tearing of the eyes. Avoid contact with the eyes.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Neurologic Disease [ see Warnings and Precautions (5.1) ] Contact Dermatitis [ see Warnings and Precautions (5.3) ] Eye Irritation [ see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence > 2%) are nasopharyngitis, upper respiratory tract infection, and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories, at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a controlled clinical trial, 557 subjects used Metronidazole Gel, 1% and 189 subjects used the gel vehicle once daily for up to 10 weeks. The following table summarizes selected adverse reactions that occurred at a rate of ≥1% and at a higher rate than vehicle: Table 1: Adverse Reactions That Occurred at a Rate of ≥1% and Higher than Vehicle in Subjects Treated with Metronidazole Gel, 1% for Up to 10 Weeks Preferred Term Metronidazole Gel, 1% Vehicle ( N= 557) N (%) ( N= 189) N (%) Influenza 8 (1.4) 1 (0.5) Upper respiratory tract infection 14 (2.5) 4 (2.1) Urinary tract infection 6 (1.1) 1 (0.5) Headache 12 (2.2) 1 (0.5) Contact dermatitis 7 (1.3) 1 (0.5) Hypertension 6 (1.1) 1 (0.5) Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than Baseline in Subjects Treated with Metronidazole Gel, 1% for Up to 10 Weeks Metronidazole Gel, 1% Vehicle Sign/Symptom ( N= 544) N (%) ( N= 184) N (%) Dryness 138 (25.4) 63 (34.2) Mild 93 (17.1) 41 (22.3) Moderate 42 (7.7) 20 (10.9) Severe 3 (0.6) 2 (1.1) Scaling 134 (24.6) 60 (32.6) Mild 88 (16.2) 32 (17.4) Moderate 43 (7.9) 27 (14.7) Severe 3 (0.6) 1 (0.5) Pruritus 86 (15.8) 35 (19.0) Mild 53 (9.7) 21 (11.4) Moderate 27 (5.0) 13 (7.1) Severe 6 (1.1) 1 (0.5) Stinging/burning 56 (10.3) 28 (15.2) Mild 39 (7.2) 18 (9.8) Moderate 7 (1.3) 9 (4.9) Severe 10 (1.8) 1 (0.5) The following additional adverse experiences have been reported with the topical use of metronidazole: transient redness, metallic taste, tingling or numbness of extremities, and nausea.

6.2Post Marketing Experience The following adverse reaction has been identified during post-approval use of topical metronidazole. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure. Nervous System Disorders: Peripheral neuropathy Ophthalmic Adverse Reactions: Tearing of the eyes

🔄 Drug Interactions 74 words ▾

7 DRUG INTERACTIONS Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Use caution when prescribing for patients who are receiving anticoagulant treatment. Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time.

Use caution when administering Metronidazole Gel, 1% concomitantly to patients who are receiving anticoagulant treatment. ( 7 )

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended. ( 8.2 )

8.1Pregnancy Risk Summary Available data have not established an association with metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. No fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. The available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of Metronidazole Gel, 1%.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2Lactation Risk Summary It is not known whether metronidazole is present in human milk after topical administration. Published literature reports the presence of metronidazole in human milk after oral administration. There are no data on the effects of metronidazole on milk production. Because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with Metronidazole Gel, 1%.

8.4Pediatric Use Safety and effectiveness of Metronidazole Gel, 1% have not been established in pediatric patients.

8.5Geriatric Use Sixty-six subjects aged 65 years and older were treated with Metronidazole Gel, 1% in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🤰 Pregnancy 133 words ▾

8.1Pregnancy Risk Summary Available data have not established an association with metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. No fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. The available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of Metronidazole Gel, 1%.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

🧒 Pediatric Use 17 words ▾

8.4Pediatric Use Safety and effectiveness of Metronidazole Gel, 1% have not been established in pediatric patients.

🧓 Geriatric Use 63 words ▾

8.5Geriatric Use Sixty-six subjects aged 65 years and older were treated with Metronidazole Gel, 1% in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology 146 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of metronidazole in the treatment of rosacea is unknown.

12.2Pharmacodynamics The pharmacodynamics of metronidazole in association with the treatment of rosacea are unknown. Cardiac Electrophysiology: The effect of Metronidazole Gel, 1% on the QTc interval has not been adequately characterized.

12.3Pharmacokinetics Topical administration of a one gram dose of Metronidazole Gel, 1% to the face of 13 subjects with moderate to severe rosacea once daily for 7 days resulted in a mean ± SD C max of metronidazole of 32 ± 9 ng/mL. The mean ± SD AUC (0-24) was 595 ± 154 ng*hr/mL. The mean C max and AUC (0-24) are less than 1% of the value reported for a single 250 mg oral dose of metronidazole.

The time to maximum plasma concentration (T max ) was 6-10 hours after topical application.

🧬 Mechanism of Action 17 words ▾

12.1Mechanism of Action The mechanism of action of metronidazole in the treatment of rosacea is unknown.

📦 How Supplied / Storage and Handling 51 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Metronidazole Gel, 1% is clear, colorless to pale yellow in color, and supplied as follows: 60 gram tube – NDC 66993-936-61 Storage and Handling Store at controlled room temperature: 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).

📋 Description 117 words ▾

11 DESCRIPTION Metronidazole Gel, 1% is a nitromidazole for topical use. Metronidazole Gel, 1% is a clear, colorless to pale yellow, aqueous gel. Each gram contains 10 mg of metronidazole.

Chemically, metronidazole is 2-methyl-5-nitro-1 H- imidazole-1-ethanol. The molecular formula for metronidazole is C 6 H 9 N 3 O 3 . It has the following structural formula: Metronidazole has a molecular weight of 171.16.

It is a white to pale yellow crystalline powder. It is slightly soluble in alcohol and has solubility in water of 10 mg/mL at 20˚C. Metronidazole belongs to the nitroimidazole class of compounds.

The inactive ingredients are betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water. Structural Formula

💬 Information for Patients 141 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Administration Instructions Use as directed. Avoid contact with the eyes [ see Warnings and Precautions ( 5.4 ) ] Cleanse treated areas before the application of Metronidazole Gel, 1% [ see Dosage and Administration ( 2 ) ] Advise patients to report any adverse reaction to their healthcare providers.

Neurologic Disease Advise patients to immediately report any abnormal neurologic signs to their healthcare provider [ see Warnings and Precautions ( 5.1 ) ] Lactation Advise women not to breastfeed during treatment with Metronidazole Gel, 1% [see Use in Specific Populations ( 8.2 )]. RX Only US Patent No. 6,881,726 and 7,348,317 Manufactured by: G Production Inc.

Baie d'Urfé, QC, H9X 3S4 Canada Made in Canada Marketed by: Prasco Laboratories Mason, OH 45040 USA P53604-2 Rev. 02/2024

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION Metronidazole Gel, 1% (meh·truh·nai·duh·zowl) Important: Metronidazole Gel, 1% is for use on the skin only (topical use). Do not use Metronidazole Gel, 1% in your mouth, eyes, or vagina. What is Metronidazole Gel, 1%?

Metronidazole Gel, 1% is a prescription medicine used on the skin (topical) to treat pimples and bumps (inflammatory lesions) caused by a condition called rosacea. It is not known if Metronidazole Gel, 1% is safe and effective in children. Do not use Metronidazole Gel, 1% if you are allergic to metronidazole or any of the ingredients in Metronidazole Gel, 1%.

See the end of this leaflet for a complete list of ingredients in Metronidazole Gel, 1%. Before using Metronidazole Gel, 1%, tell your healthcare provider about all your medical conditions, including if you: have tingling or numbness in your hands or feet have or have had a blood disorder or disease are pregnant or plan to become pregnant. It is not known if Metronidazole Gel, 1% will harm your unborn baby. are breastfeeding or plan to breastfeed.

It is not known if Metronidazole Gel, 1% passes into your breast milk. Do not breastfeed during treatment with Metronidazole Gel, 1%. Talk to your healthcare provider about the best way to feed your baby during treatment with Metronidazole Gel, 1%.

Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Metronidazole Gel, 1%? Use Metronidazole Gel, 1% exactly as your healthcare provider tells you to. Cleanse the treated area before applying Metronidazole Gel, 1%.

Apply and rub in a thin film of Metronidazole Gel, 1% 1 time a day to the affected area(s). You can apply cosmetics after applying Metronidazole Gel, 1%. Avoid contact of Metronidazole Gel, 1% with your eyes.

What are the possible side effects of Metronidazole Gel, 1%? Metronidazole Gel, 1% may cause serious side effects, including: P eripheral neuropathy. Tingling, burning, pain or numbness in the hands or feet (peripheral neuropathy) have happened in people treated with metronidazole used on the skin.

Tell your healthcare provider if you experience tingling, burning, pain or numbness in your hands or feet during treatment with Metronidazole Gel, 1%. Skin reactions, including allergic reactions. Tell your healthcare provider if you develop any skin reactions, including rash, itching, redness, swelling, or blisters during treatment with Metronidazole Gel, 1%.

Eye irritation. Tearing from eye irritation has happened in people treated with metronidazole used on the skin. Tell your healthcare provider if you experience tearing, redness or discomfort of the eyes during treatment with Metronidazole Gel, 1%.

The most common side effects of Metronidazole Gel, 1% include : sore throat and nasal congestion upper respiratory tract infections headache Tell your healthcare provider if you get any side effects during treatment with Metronidazole Gel, 1%. These are not all of the possible side effects of Metronidazole Gel, 1%. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Prasco Laboratories at 1-866-525-0688. How should I store Metronidazole Gel, 1%?

Store Metronidazole Gel, 1% at room temperature between 68°F to 77°F (20°C to 25°C). Keep Metronidazole Gel, 1% and all medicines out of the reach of children. General information about the safe and effective use of Metronidazole Gel, 1% .

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Metronidazole Gel, 1% for a condition for which it was not prescribed. Do not give Metronidazole Gel, 1% to other people, even if they have the same symptoms that you have.

It may harm them. You can ask your pharmac…

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