Ivermectin 10 mg/g Cream — NDC 0591-4052-89 (Billing 00591-4052-89)
This is a package of Ivermectin 10 mg/g Cream from Actavis Pharma, Inc., marketed since Oct 2019 and currently FDA-listed; retail pharmacies pay about $2.75 per g (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0591-4052-89 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0591 labeler · 4052 product · 89 package
- Package marketed since
- Oct 14, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0591405289 4
- Medicaid fills, this package
- 1,317 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 073235
- GCN: 37612
- GPI-14 (Medi-Span): 90060030003720
- HICL (First Databank): 010933
- AHFS class code: 84:92.00.00
- RxCUI (RxNorm): 1598068
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Antiparasitic class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the product. Tablets treat intestinal strongyloidiasis and onchocerciasis. Lotions treat head lice, and the cream treats the bumps and pimples of rosacea.
- Stromectol and ivermectin tablets are usually a single dose based on your weight. Take it on an empty stomach with water. Your doctor may order follow-up stool tests to confirm the...
- Apply it to dry hair and scalp, covering everything from the scalp outward. Leave it on for 10 minutes, then rinse with water only. Wait 24 hours before shampooing, and don't reuse...
- Dizziness, itching, rash, nausea, diarrhea, and tiredness were reported. If you're treated for onchocerciasis, fever, swollen glands, and joint pain can happen as the parasites die...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ivermectin — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $2.746 | $123.57 / 45 g |
| Medicaid paysCMS SDUD · 12 mo | $5.97 | $268.56 / 45 g |
| Medicare drug plans payPart D · Q2 2026 | $7.33 | $329.83 / 45 g |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00591-4052-89 You're viewing this Main listing | 1 TUBE in 1 CARTON / 45 g in 1 TUBE | 2019-10-14 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ivermectin 10 mg/gthis 00591-4052-89 | Actavis | 1 tube | $2.746 | AB | Availability likely | — |
| Ivermectin 10 mg/g 45802-0102-84 | Padagis | 1 tube | $2.746 | AB | Availability likely | — |
| Ivermectin 10 mg/g 68308-0701-45 | Mayne | 1 tube | $2.746 | AB | Availability likely | — |
| Soolantra 10 mg/g 00299-3823-00 | Galderma | 2 g | — | AB | FDA listed | — |
| Ivermectin 10 mg/g 63629-8754-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| ivermectin 10 mg/g 70771-1728-02 | Zydus | 1 tube | — | AB | FDA listed | — |
| Ivermectin 10 mg/g 71335-2946-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ivermectin 10 mg/g 72162-2294-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| ivermectin 10 mg/g 72578-0120-02 | Viona | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Ivermectin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII 4Q93RCW27E
A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
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UNII P7E6YFV72X
Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII KEH0A3F75J
Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII 172F2WN8DV
A fatty alcohol derived from animal or plant oils. It acts as an emollient and helps stabilize emulsions, allowing oil and water to mix evenly in the medication.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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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.
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UNII 6LUM696811
A waxy substance derived from sorbitol and stearic acid. It acts as an emulsifier and stabilizer to help mix oil and water components evenly throughout the medicine and prevent separation.
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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.
14 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Actavis Pharma, Inc. labeler code 00591
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- Penicillamine 250 mg Capsule NDC 0591-4171-00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Ivermectin cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Ivermectin cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply to the affected areas of the face once daily. Use a pea-size amount for each area of the face (forehead, chin, nose, each cheek) that is affected. Spread as a thin layer, avoiding the eyes and lips. Ivermectin cream is not for oral, ophthalmic, or intravaginal use. Apply to the affected areas once daily. ( 2 ) Not for oral, ophthalmic or intravaginal use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Cream, 1%. Each gram of ivermectin cream contains 10 mg of ivermectin, USP in a white to pale yellow cream base. Ivermectin cream is supplied in tubes of 45 g. Cream, 1%, ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS In controlled clinical trials with ivermectin cream the most common adverse reactions (incidence ≤ 1 %) included skin burning sensation and skin irritation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 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. During clinical trials, 2,047 subjects with inflammatory lesions of rosacea received ivermectin cream once daily. A total of 1,555 subjects were treated once daily for more than 12 weeks, and 519 for approximately one year.
Adverse reactions, reported in ≤ 1% of subjects treated with ivermectin cream for at least 3 months in vehicle-controlled clinical trials, included skin burning sensation and skin irritation.
6.2Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Local adverse reactions: contact dermatitis and allergic dermatitis.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS In vitro studies have shown that ivermectin cream, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary The available data on the use of ivermectin, including ivermectin cream, in pregnant women are insufficient to establish a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, ivermectin induced adverse developmental outcomes when orally administered to pregnant rats and rabbits during the period of organogenesis at doses 1909 or 354 times the maximum recommended human dose (MRHD), respectively. These orally administered doses were maternally toxic to pregnant rats and rabbits.
In a pre-and postnatal developmental study in rats, neonatal toxicity and adverse effects on behavioral development were observed when ivermectin was orally administered to pregnant females during gestation and lactation ( see Data ). 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 to 4% and 15 to 20%, respectively. Data Human Data No adequate and well-controlled trials of ivermectin cream have been conducted in pregnant women. Retrospective observational studies evaluated pregnancy outcomes in over 700 women in various stages of pregnancy who received oral ivermectin for the treatment of soil-transmitted helminths in rural Africa.
In an additional, randomized open-label trial, 397 pregnant women in their second trimester received a single dose of oral ivermectin, or ivermectin plus albendazole, for soil-transmitted helminths. When compared with a pregnant, untreated population, no differences in pregnancy outcomes were observed between the treated and untreated populations. These studies cannot definitively establish or exclude any drug-associated risk during pregnancy, because either the timing of administration during gestation was not accurately ascertained or the administration occurred only during the second trimester.
Animal Data Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 1.5, 4, and 12 mg/kg/day ivermectin were administered during the period of organogenesis to pregnant female rats. Maternal death occurred at 12 mg/kg/day [1909 times the MRHD based on area under the curve (AUC) comparison].
Cleft palate occurred in the fetuses from the 12 mg/kg/day (1909 times the MRHD based on AUC comparison) group. No treatment related embryofetal toxicity or malformations were noted at 4 mg/kg/day (708 times the MRHD based on AUC comparison). Oral doses of 0.5, 1.5, 2.5, 3.5 and 4.5 mg/kg/day ivermectin were administered during the period of organogenesis to pregnant female rabbits.
Maternal death occurred at doses ≥ 2.5 mg/kg/day (72 times the MRHD based on AUC comparison). Carpal flexure occurred in the fetuses from the 4.5 mg/kg/day (354 times the MRHD based on AUC comparison) group. Fetal weight decrease was noted at 3.5 mg/kg/day (146 times the MRHD based on AUC comparison).
No treatment related embryofetal toxicity or malformations were noted at 2.5 mg/kg/day (72 times the MRHD based on AUC comparison). A pre- and post-natal development study was conducted in rats. Oral doses of 1, 2 and 4 mg/kg/day ivermectin were administered to pregnant female rats during gestational days 6 to 20 and lactation days 2 to 20.
Neonatal death occurred at doses ≥ 2 mg/kg/day. Behavior development of newborn rats was adversely affected at all doses.
8.2Lactation Risk Summary The presence of ivermectin in human milk following topical administration of ivermectin has not been evaluated. There are no data available regarding the effects of ivermectin on milk production. Published literature suggests that ivermectin was detectable in human milk in 4 lactating women after a single 150 mcg/kg oral dose of ivermectin. How… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The available data on the use of ivermectin, including ivermectin cream, in pregnant women are insufficient to establish a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, ivermectin induced adverse developmental outcomes when orally administered to pregnant rats and rabbits during the period of organogenesis at doses 1909 or 354 times the maximum recommended human dose (MRHD), respectively. These orally administered doses were maternally toxic to pregnant rats and rabbits.
In a pre-and postnatal developmental study in rats, neonatal toxicity and adverse effects on behavioral development were observed when ivermectin was orally administered to pregnant females during gestation and lactation ( see Data ). 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 to 4% and 15 to 20%, respectively. Data Human Data No adequate and well-controlled trials of ivermectin cream have been conducted in pregnant women. Retrospective observational studies evaluated pregnancy outcomes in over 700 women in various stages of pregnancy who received oral ivermectin for the treatment of soil-transmitted helminths in rural Africa.
In an additional, randomized open-label trial, 397 pregnant women in their second trimester received a single dose of oral ivermectin, or ivermectin plus albendazole, for soil-transmitted helminths. When compared with a pregnant, untreated population, no differences in pregnancy outcomes were observed between the treated and untreated populations. These studies cannot definitively establish or exclude any drug-associated risk during pregnancy, because either the timing of administration during gestation was not accurately ascertained or the administration occurred only during the second trimester.
Animal Data Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 1.5, 4, and 12 mg/kg/day ivermectin were administered during the period of organogenesis to pregnant female rats. Maternal death occurred at 12 mg/kg/day [1909 times the MRHD based on area under the curve (AUC) comparison].
Cleft palate occurred in the fetuses from the 12 mg/kg/day (1909 times the MRHD based on AUC comparison) group. No treatment related embryofetal toxicity or malformations were noted at 4 mg/kg/day (708 times the MRHD based on AUC comparison). Oral doses of 0.5, 1.5, 2.5, 3.5 and 4.5 mg/kg/day ivermectin were administered during the period of organogenesis to pregnant female rabbits.
Maternal death occurred at doses ≥ 2.5 mg/kg/day (72 times the MRHD based on AUC comparison). Carpal flexure occurred in the fetuses from the 4.5 mg/kg/day (354 times the MRHD based on AUC comparison) group. Fetal weight decrease was noted at 3.5 mg/kg/day (146 times the MRHD based on AUC comparison).
No treatment related embryofetal toxicity or malformations were noted at 2.5 mg/kg/day (72 times the MRHD based on AUC comparison). A pre- and post-natal development study was conducted in rats. Oral doses of 1, 2 and 4 mg/kg/day ivermectin were administered to pregnant female rats during gestational days 6 to 20 and lactation days 2 to 20.
Neonatal death occurred at doses ≥ 2 mg/kg/day. Behavior development of newborn rats was adversely affected at all doses.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of ivermectin cream in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 1,371 subjects in the two pivotal clinical studies of ivermectin cream, 170 (12.4%) were 65 and over, while 37 (2.7%) were 75 and over. 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.
🆘 Overdosage ▾
10 OVERDOSAGE In accidental or significant exposure to unknown quantities of veterinary formulations of ivermectin in humans, either by ingestion, inhalation, injection, or exposure to body surfaces, the following adverse effects have been reported most frequently: rash, edema, headache, dizziness, asthenia, nausea, vomiting, and diarrhea. Other adverse effects that have been reported include: seizure, ataxia, dyspnea, abdominal pain, paresthesia, urticaria, and contact dermatitis. In case of accidental ingestion, supportive therapy, if indicated, should include parenteral fluids and electrolytes, respiratory support (oxygen and mechanical ventilation if necessary) and pressor agents if clinically significant hypotension is present.
Induction of emesis and/or gastric lavage as soon as possible, followed by purgatives and other routine anti-poison measures, may be indicated if needed to prevent absorption of ingested material.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of ivermectin cream in treating rosacea lesions is unknown.
12.2Pharmacodynamics Cardiac Electrophysiology At therapeutic doses, ivermectin cream is not expected to prolong QTc interval.
12.3Pharmacokinetics Absorption The absorption of ivermectin from ivermectin cream was evaluated in a clinical trial in 15 adult male and female subjects with severe papulopustular rosacea applying 1 g ivermectin cream, 1% once daily. At steady state (after 2 weeks of treatment), the highest mean ± standard deviation) plasma concentrations of ivermectin peaked (T max ) at 10 ± 8 hours post-dose, the maximum concentration (C max ) was 2.10 ± 1.04 ng/mL (range: 0.69 to 4.02 ng/mL) and the area under the concentration curve (AUC 0-24hr ) was 36.14 ± 15.56 ng.hr/mL (range: 13.69 to 75.16 ng•hr/mL).
In addition, systemic exposure assessment in longer treatment duration (Phase 3 studies) showed that there was no plasma accumulation of ivermectin over the 52-week treatment period. Distribution An in vitro study demonstrated that ivermectin is greater than 99% bound to plasma proteins and is bound primarily to human serum albumin. No significant binding of ivermectin to erythrocytes was observed.
Metabolism In vitro studies using human hepatic microsomes and recombinant CYP450 enzymes have shown that ivermectin is primarily metabolized by CYP3A4. In vitro studies show that ivermectin at therapeutic concentrations does not inhibit the CYP450 isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 or 4A11, or induce 1A2, 2B6, 2C9 or 3A4. Excretion The apparent terminal half-life averaged 6.5 days (mean ± standard deviation: 155± 40 hours, range 92 to 238 hours) in patients receiving a once daily cutaneous application of ivermectin cream for 28 days.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of ivermectin cream in treating rosacea lesions is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Ivermectin cream, 1% is a white to pale yellow cream, supplied in a laminated tube with a child resistant cap in the following size: 45 gram - NDC 0591- 4052 -89 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Ivermectin cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of ivermectin cream contains 10 mg of ivermectin, USP. Ivermectin, USP is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones.
Ivermectin, USP is a mixture containing not less than 95.0 % and not more than 102.0 % of 5-O-demethyl-22,23-dihydroavermectin A 1a plus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a , generally referred to as 22,23-dihydroavermectin B 1a and B 1b or H 2 B 1a and H 2 B 1b , respectively; and the ratio (calculated by area percentage) of component H 2 B 1a /(H 2 B 1a + H 2 B 1b )) is not less than 90.0 %. The respective molecular formulas of H 2 B 1a and H 2 B 1b are C 48 H 74 O 14 and C 47 H 72 O 14 with molecular weights of 875.10 and 861.07 respectively.
The structural formulas are: Component H 2 B 1a : R = C 2 H 5 , Component H 2 B 1b : R = CH 3 . Ivermectin cream, 1% contains the following inactive ingredients: benzyl alcohol, citric acid anhydrous, carbomer homopolymer type c, di-isopropyl adipate, edetate disodium, hexylene glycol, methylparaben, oleyl alcohol, polysorbate 80, propylparaben, purified water, sodium citrate, sodium hydroxide, and sorbitan tristearate. 1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Patients using ivermectin cream should receive the following instruction: Keep out of reach of children. Manufactured By: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. C 5/2025
🍼 Nursing Mothers ▾
8.2Lactation Risk Summary The presence of ivermectin in human milk following topical administration of ivermectin has not been evaluated. There are no data available regarding the effects of ivermectin on milk production. Published literature suggests that ivermectin was detectable in human milk in 4 lactating women after a single 150 mcg/kg oral dose of ivermectin.
However, there is insufficient information from this report to determine the effects of ivermectin on the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ivermectin cream and any potential adverse effects on the breastfed infant from ivermectin cream or from the underlying maternal conditions.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption The absorption of ivermectin from ivermectin cream was evaluated in a clinical trial in 15 adult male and female subjects with severe papulopustular rosacea applying 1 g ivermectin cream, 1% once daily. At steady state (after 2 weeks of treatment), the highest mean ± standard deviation) plasma concentrations of ivermectin peaked (T max ) at 10 ± 8 hours post-dose, the maximum concentration (C max ) was 2.10 ± 1.04 ng/mL (range: 0.69 to 4.02 ng/mL) and the area under the concentration curve (AUC 0-24hr ) was 36.14 ± 15.56 ng.hr/mL (range: 13.69 to 75.16 ng•hr/mL).
In addition, systemic exposure assessment in longer treatment duration (Phase 3 studies) showed that there was no plasma accumulation of ivermectin over the 52-week treatment period. Distribution An in vitro study demonstrated that ivermectin is greater than 99% bound to plasma proteins and is bound primarily to human serum albumin. No significant binding of ivermectin to erythrocytes was observed.
Metabolism In vitro studies using human hepatic microsomes and recombinant CYP450 enzymes have shown that ivermectin is primarily metabolized by CYP3A4. In vitro studies show that ivermectin at therapeutic concentrations does not inhibit the CYP450 isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 or 4A11, or induce 1A2, 2B6, 2C9 or 3A4. Excretion The apparent terminal half-life averaged 6.5 days (mean ± standard deviation: 155± 40 hours, range 92 to 238 hours) in patients receiving a once daily cutaneous application of ivermectin cream for 28 days.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Cardiac Electrophysiology At therapeutic doses, ivermectin cream is not expected to prolong QTc interval.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Ivermectin cream applied once daily at bedtime was evaluated in the treatment of inflammatory lesions of rosacea in two randomized, double-blind, vehicle-controlled clinical trials, which were identical in design. The trials were conducted in 1,371 subjects aged 18 years and older who were treated once daily for 12 weeks with either ivermectin cream or vehicle cream. Overall, 96% of subjects were Caucasian and 67% were female.
Using the 5-point Investigator Global Assessment (IGA) scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe), 79% of subjects were scored as moderate (IGA=3) and 21% scored as severe (IGA=4) at baseline. The co-primary efficacy endpoints in both pivotal trials were the success rate based on the IGA outcome (percentage of subjects “clear” and “almost clear”) and absolute change from baseline in inflammatory lesion counts at Week 12. Table 1 presents the co-primary efficacy results at Week 12.
Ivermectin cream was more effective than vehicle cream on the co-primary efficacy endpoints starting from 4 weeks of treatment in both studies, see Figures 1 through 4. Table 1: Co-Primary Efficacy Results at Week 12 Study 1 Study 2 Ivermectin Vehicle Ivermectin Vehicle Cream (N=451) Cream (N=232) Cream (N=459) Cream (N=229) Investigator Global Assessment: Number (%) of Subjects Clear or Almost Clear 173 (38.4%) 27 (11.6%) 184 (40.1%) 43 (18.8%) Inflammatory Lesion Counts: Mean Absolute (%) Change from Baseline 20.5 (64.9%) 12.0 (41.6%) 22.2 (65.7%) 13.4 (43.4%) Figures 1 and 2: IGA Success Rates Over Time Figures 3 and 4: Mean Absolute Change in Inflammatory Lesion Counts from Baseline Over Time 1 2
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year dermal mouse carcinogenicity study, ivermectin was administered to CD-1 mice at topical doses of 1, 3, and 10 mg/kg/day (0.1%, 0.3% and 1% ivermectin cream applied at 2 mL/kg/day). No drug-related tumors were noted in this study up to the highest dose evaluated in this study of 10 mg/kg/day (747 times the MRHD based on AUC comparison). In a 2-year oral rat carcinogenicity study, ivermectin was administered to Wistar rats at gavage doses of 1, 3, and 9 mg/kg/day.
A statistically significant increase in the incidence of hepatocellular adenoma was noted in males treated with 9 mg/kg/day (1766 times the MRHD based on AUC comparison) ivermectin. The clinical relevance of this finding is unknown. No drug-related tumors were noted in females up to the highest dose evaluated in this study of 9 mg/kg/day (1959 times the MRHD based on AUC comparison).
No drug-related tumors were noted in males at doses ≤ 3 mg/kg/day (599 times the MRHD based on AUC comparison). Ivermectin revealed no evidence of genotoxic potential based on the results of two in vitro genotoxicity tests (the Ames test and the L5178Y/TK +/- mouse lymphoma assay) and one in vivo genotoxicity test (rat micronucleus assay). In a fertility study, oral doses of 0.1, 1, and 9 mg/kg/day ivermectin were administered to male and female rats.
Mortality occurred at 9 mg/kg/day (1027 times the MRHD based on AUC comparison). The precoital period was generally prolonged at 9 mg/kg/day. No treatment related effects on fertility or mating performance were noted at doses ≤ 1 mg/kg/day (68 times the MRHD based on AUC comparison).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year dermal mouse carcinogenicity study, ivermectin was administered to CD-1 mice at topical doses of 1, 3, and 10 mg/kg/day (0.1%, 0.3% and 1% ivermectin cream applied at 2 mL/kg/day). No drug-related tumors were noted in this study up to the highest dose evaluated in this study of 10 mg/kg/day (747 times the MRHD based on AUC comparison). In a 2-year oral rat carcinogenicity study, ivermectin was administered to Wistar rats at gavage doses of 1, 3, and 9 mg/kg/day.
A statistically significant increase in the incidence of hepatocellular adenoma was noted in males treated with 9 mg/kg/day (1766 times the MRHD based on AUC comparison) ivermectin. The clinical relevance of this finding is unknown. No drug-related tumors were noted in females up to the highest dose evaluated in this study of 9 mg/kg/day (1959 times the MRHD based on AUC comparison).
No drug-related tumors were noted in males at doses ≤ 3 mg/kg/day (599 times the MRHD based on AUC comparison). Ivermectin revealed no evidence of genotoxic potential based on the results of two in vitro genotoxicity tests (the Ames test and the L5178Y/TK +/- mouse lymphoma assay) and one in vivo genotoxicity test (rat micronucleus assay). In a fertility study, oral doses of 0.1, 1, and 9 mg/kg/day ivermectin were administered to male and female rats.
Mortality occurred at 9 mg/kg/day (1027 times the MRHD based on AUC comparison). The precoital period was generally prolonged at 9 mg/kg/day. No treatment related effects on fertility or mating performance were noted at doses ≤ 1 mg/kg/day (68 times the MRHD based on AUC comparison).
📄 Patient Package Insert ▾
PATIENT INFORMATION Ivermectin (eye" ver mek' tin) Cream, 1% Important: Ivermectin cream is for use on the skin only (topical use). Do not use ivermectin cream in your mouth, eyes, or vagina. What is ivermectin cream?
Ivermectin cream 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 ivermectin cream is safe and effective in children. Before using ivermectin cream, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant.
It is not known if ivermectin cream will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ivermectin passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ivermectin cream.
Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use ivermectin cream? See the detailed “Instructions for Use” that comes with ivermectin cream for information on how to apply ivermectin cream.
Use ivermectin cream exactly as your healthcare provider tells you to. Apply ivermectin cream to the affected areas of your face 1 time a day. Avoid contact with your eyes and lips If ivermectin cream is accidentally swallowed (ingested), call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of ivermectin cream? The most common side effects of ivermectin cream include skin burning sensation and skin irritation. These are not all of the possible side effects of ivermectin cream.
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 Teva at 1-888-838-2872.
How should I store ivermectin cream? Store ivermectin cream at room temperature between 68°F to 77°F (20°C to 25°C). Keep ivermectin cream and all medicines out of the reach of children.
General information about the safe and effective use of ivermectin cream. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ivermectin cream for a condition for which it was not prescribed.
Do not give ivermectin cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ivermectin cream that is written for health professionals.
What are the ingredients in ivermectin cream? Active ingredient: ivermectin Inactive ingredients: benzyl alcohol, citric acid anhydrous, carbomer homopolymer type c, di-isopropyl adipate, edetate disodium, hexylene glycol, methylparaben, oleyl alcohol, polysorbate 80, propylparaben, purified water, sodium citrate, sodium hydroxide, and sorbitan tristearate Manufactured By: Teva Pharmaceuticals , Parsippany, NJ 07054 For more information, call Teva at 1-888-838-2872. This Patient Information has been approved by the U.S.
Food and Drug Administration. Rev. B 5/2025
📖 Instructions for Use ▾
INSTRUCTION FOR USE Ivermectin (eye" ver mek' tin) Cream, 1% Important: Ivermectin cream is for use on the skin only (topical use). Do not use ivermectin cream in your mouth, eyes, or vagina. Read and follow the steps below so that you use ivermectin cream correctly.
1. Open the tube of ivermectin cream by gently pressing down on the child resistant cap and twist in the direction of the arrow (counterclockwise) as shown below. See Figures A and B.
To avoid spilling, do not squeeze the tube while opening or closing. Figure A Figure B 2. To apply ivermectin cream to your face, squeeze a pea-sized amount of ivermectin cream from the tube onto your fingertip.
See Figure C. Figure C 3. Apply ivermectin cream to the affected areas of your face 1 time a day.
Use a pea-sized amount of ivermectin cream for each area of your face (forehead, chin, nose, each cheek) that is affected. Spread the cream smoothly and evenly in a thin layer. Avoid contact with your eyes and lips.
4. To close ivermectin cream, gently press down on the child resistant cap and twist to the right (clockwise). See Figure D.
Figure D How should I store ivermectin cream? Store ivermectin cream at room temperature between 68°F to 77°F (20°C to 25°C). Keep ivermectin cream and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured By: Teva Pharmaceuticals Parsippany, NJ 07054 Rev.
C 5/2025 1 1 3 4
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0591- 4052 -89 Rx only Ivermectin Cream 1% FOR TOPICAL USE ONLY Not for Oral, Ophthalmic, or Intravaginal Use 45 GRAMS 1