ertaczo
Ertaczo (Sertaconazole Nitrate) is a medication used to treat Tinea Pedis.
Sertaconazole Nitrate · by Lacer Pharma
Key facts
- Active ingredient
- Sertaconazole Nitrate
- Form
- Topical
- Strength
- Sertaconazole Nitrate 2%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- tinea pedis
- Manufacturer
- Lacer Pharma
- FDA application
- NDA021385
What is Ertaczo?
From the FDA label:ERTACZO (sertaconazole nitrate) cream, 2%, is for topical application. It contains the azole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers. Sertaconazole nitrate is designated chemically as (±)-1-[2,4-dichloro-β-[(7-chlorobenzo-[ b ]thien-3-yl)methoxy]phenethyl]imidazole nitrate. It has a molecular weight of 500.8. The molecular formula is C 20 H 15 Cl 3 N 2 OS ● HNO 3 , and the structural formula is as follows: Sertaconazole nitrate is a white or almost white powder. It is practically insoluble in water, soluble in methanol, and sparingly soluble in alcohol and in methylene chloride. Each gram of ERTACZO cream, 2%, contains 17.5 mg of sertaconazole (as sertaconazole nitrate, 20 mg) in a white cream base of ethylene glycol, glyceryl isostearate, glycolized saturated glycerides, light mineral oil, methylparaben, polyethylene glycol palmitostearate, polyoxyethylened saturated glycerides, purified water, and sorbic acid. Sertaconzole nitrate chemical structure
How to use
Apply ERTACZO cream, 2% twice daily for 4 weeks. Apply a sufficient amount of ERTACZO cream, 2% to cover both the affected areas between the toes and the immediately surrounding healthy skin. Use ERTACZO cream, 2% for the full treatment time recommended by the physician, even though symptoms may have improved. Dry the affected area(s) thoroughly before application, if using ERTACZO cream, 2% after bathing. Wash hands after use. Avoid the use of occlusive dressings or wrappings. For topical use. Not for ophthalmic, oral, or intravaginal use. Apply ERTACZO cream, 2% to the affected and immediate surrounding area(s) twice daily for 4 weeks. ( 2 ) Not for ophthalmic, oral, or intravaginal use. ( 2 )
Side effects
Most common adverse reactions observed in clinical trials (incidence >2%) were contact dermatitis, dry skin, burning skin, application site skin tenderness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lacer Pharma, LLC at 1-888-403-8874 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving ERTACZO cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, and application site skin tenderness. In a dermal sensitization trial, 8 of 202 evaluable subjects tested with ERTACZO cream, 2%, and 4 of 202 evaluable subjects tested with vehicle exhibited a erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ERTACZO cream, 2%. Because…
Warnings
Important safety information
5.1 Local Adverse Reactions If irritation develops, discontinue treatment and institute appropriate therapy. Physicians should exercise caution when prescribing ERTACZO cream, 2%, to patients known to be sensitive to azole antifungals since cross-reactivity may occur.
Who should not take Ertaczo
None. None. ( 4 )
May treat (source: NIH RxClass)
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Ertaczo treat?
- Ertaczo (Sertaconazole Nitrate) may be used to treat tinea pedis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Ertaczo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ertaczo. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ertaczo?
- Ertaczo is marketed by Lacer Pharma. You can see Lacer Pharma's full profile, rating, and other products on pharmaranks.
- Is Ertaczo a brand-name or generic drug?
- Ertaczo is a brand-name product with the active ingredient Sertaconazole Nitrate.
- Is Ertaczo available over the counter?
- No. Ertaczo is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ertaczo come in?
- Ertaczo is currently marketed as topical, per the FDA's National Drug Code Directory.
- Is Ertaczo FDA-registered?
- Ertaczo is on record with the U.S. FDA under application number NDA021385. You can verify this on its official FDA label.
- Is Ertaczo safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Ertaczo. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Ertaczo?
- Ertaczo's side effects are taken directly from its FDA label. From the label: Most common adverse reactions observed in clinical trials (incidence >2%) were contact dermatitis, dry skin, burning skin, application site skin tenderness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lacer Pharma, LLC at 1-888-403-8874 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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