Mometasone Furoate 1 mg/g Ointment
Other active recalls for Mometasone Furoate (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Mometasone topical is used to relieve the redness, swelling, itching and inflammation and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Mometasone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Read the full MedlinePlus article ↗- For the nasal spray, it can help with allergy symptoms, but it works best as a daily preventive — not a quick-fix spray you grab when symptoms hit suddenly. For the inhalers (Asman...
- Can I use my mometasone nasal spray or inhaler when I'm having an allergy attack or asthma flare right now?
- That's actually normal — it can take one to two weeks or even longer to feel the full benefit from an inhaled corticosteroid like Asmanex. These medications work by gradually reduc...
- I've been using the Asmanex inhaler for a week and I still feel the same. Is it working?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Mometasone Furoate — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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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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Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
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Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
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Propylene glycol stearate is a waxy substance made by combining stearic acid with propylene glycol. It acts as an emulsifier to help blend oil and water ingredients, and also serves as a thickener or stabilizer in the medicine.
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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.
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White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.
6 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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.3780 | $17.01 / 45 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mometasone Furoate 1 mg/g 00713-0635-15 | Cosette | 1 tube | $0.293 | AB | Availability likely | — |
| Mometasone Furoate 1 mg 13668-0527-01 | Torrent | 15 ointments | $0.293 | AB | Availability likely | — |
| Mometasone Furoate 1 mg/g 45802-0119-37 | Padagis | 1 tube | $0.293 | AB | Availability likely | — |
| Mometasone Furoate 1 mg/g 68462-0225-17 | Glenmark | 15 g | $0.351 | — | Discontinued | — |
| Mometasone Furoate 1 mg/g 00713-0634-15 | Cosette | 1 tube | $0.429 | AB | Availability likely | — |
| Mometasone Furoate 1 mg/g 45802-0257-35 | Padagis | 1 tube | $0.429 | AB | Availability likely | — |
| Mometasone Furoate 1 mg/g 68462-0192-17 | Glenmark | 15 g | $0.483 | — | FDA listed | — |
| Mometasone furoate 1 mg/g 21922-0071-04 | Encube | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 50090-1633-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 51672-1311-01 | Sun | 1 tube | — | — | Discontinued | — |
| Mometasone Furoate 1 mg/g 63629-8683-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 63629-8684-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 63629-9305-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/gthis 63629-9306-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 68788-8357-04 | Preferred | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 71205-0413-15 | Proficient | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 72162-1393-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 85766-0181-15 | Sportpharm | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 63187-0432-15 | Proficient | 15 g | — | — | FDA listed | — |
| Mometasone Furoate 1 mg/g 50090-2991-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 72162-1404-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 51672-1315-01 | Sun | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 63629-8681-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 68788-8548-04 | Preferred | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 71335-2873-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 63187-0288-15 | Proficient | 15 g | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 68788-4075-04 | Preferred | 1 tube | — | AB | FDA listed | — |
| Mometasone Furoate 1 mg/g 63629-8682-01 | Bryant | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
⏳ 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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63629-9306-01 You're viewing this | 1 TUBE in 1 CARTON (63629-9306-1) / 45 g in 1 TUBE | 2022-07-06 | Active |
🧭 About this NDC listing & data coverage
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) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| 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. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Mometasone Furoate Ointment, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. Mometasone Furoate Ointment, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥2 years of age
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply a thin film of Mometasone Furoate Ointment, 0.1% to the affected skin areas once daily. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1)].
Do not use Mometasone Furoate Ointment, 0.1% with occlusive dressings unless directed by a physician. Do not apply Mometasone Furoate Ointment, 0.1% in the diaper area, as diapers or plastic pants constitute occlusive dressing. Avoid use on the face, groin, or axillae.
Avoid contact with eyes. Wash hands after each application. Mometasone Furoate Ointment, 0.1% is for topical use only.
It is not for oral, ophthalmic, or intravaginal use. • Apply a thin film to the affected skin areas once daily. (2) • Discontinue therapy when control is achieved. (2) • If no improvement is seen within 2 weeks, reassess diagnosis.
(2) • Do not use with occlusive dressings unless directed by a physician. (2)
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ointment, 0.1%. Each gram of Mometasone Furoate Ointment, 0.1% contains 1 mg of mometasone furoate in a white to off-white uniform ointment base. • Ointment, 0.1%. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Mometasone Furoate Ointment, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. • Mometasone Furoate Ointment, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment, Cushing’s syndrome, and hyperglycemia may occur due to systemic absorption. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. Modify use should HPA axis suppression develop.
(5.1, 8.4) • Pediatric patients may be more susceptible to systemic toxicity. (5.1, 8.4) • May increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist.
(5.2)
5.1Effects on Endocrine System Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.
In a study evaluating the effects of mometasone furoate ointment on the HPA axis, 15 grams were applied twice daily for 7 days to 6 adult subjects with psoriasis or atopic dermatitis. The results show that the drug caused a slight lowering of adrenal corticosteroid secretion. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.
Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)] .
5.2Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products, including the topical mometasone products [see Adverse Reactions (6.2)]. Avoid contact of Mometasone Furate Ointment, 0.1% with eyes.
Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
5.3Allergic Contact Dermatitis If irritation develops, Mometasone Furoate Ointment, 0.1% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.
5.4Concomitant Skin Infections If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Mometasone Furoate Ointment, 0.1% should be discontinued until the infection has been adequately controlled.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions are burning, pruritus, skin atrophy, tingling/stinging and furunculosis. (6) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 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 clinical practice. In controlled clinical trials involving 812 subjects, the incidence of adverse reactions associated with the use of mometasone furoate ointment, 0.1% was 4.8%. Reported reactions included burning, pruritus, skin atrophy, tingling/stinging, and furunculosis.
Cases of rosacea associated with the use of mometasone furoate ointment, 0.1% have been reported. The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate ointment, 0.1% during a clinical study in 5% of 63 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 1; an unspecified skin disorder, 1; and a bacterial skin infection, 1. The following signs of skin atrophy were also observed among 63 subjects treated with mometasone furoate ointment, 0.1% in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; and thinness, 1.
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. Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. These adverse reactions may occur more frequently with the use of occlusive dressings.
Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with Mometasone Furoate Ointment, 0.1%.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, Mometasone Furoate Ointment, 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification.
Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy. In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg.
No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate ointment, 0.1% on a mcg/m 2 basis). In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above.
A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate ointment, 0.1% on a mcg/m 2 basis). In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate ointment, 0.1% on a mcg/m 2 basis).
In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg.
(Doses of 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate ointment, 0.1% on a mcg/m 2 basis). When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg.
(Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate ointment, 0.1% on a mcg/m 2 basis).
8.3Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mometasone Furoate Ointment, 0.1% is administered to a nursing woman.
8.4Pediatric Use Mometasone Furoate Ointment, 0.1% may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Since safety and efficacy of Mometasone Furoate Ointment, 0.1% have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended. Mometasone furoate ointment, 0.1% caused HPA axis suppression in approximately 27% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximate…
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, Mometasone Furoate Ointment, 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification.
Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy. In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg.
No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate ointment, 0.1% on a mcg/m 2 basis). In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above.
A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate ointment, 0.1% on a mcg/m 2 basis). In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate ointment, 0.1% on a mcg/m 2 basis).
In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg.
(Doses of 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate ointment, 0.1% on a mcg/m 2 basis). When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg.
(Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate ointment, 0.1% on a mcg/m 2 basis).
🧒 Pediatric Use ▾
8.4Pediatric Use Mometasone Furoate Ointment, 0.1% may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Since safety and efficacy of Mometasone Furoate Ointment, 0.1% have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended. Mometasone furoate ointment, 0.1% caused HPA axis suppression in approximately 27% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 39% (range 15%-99%).
The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 3 subjects, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population [see Clinical Pharmacology (12.2)] .
Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of glucocorticosteroid insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids.
Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Mometasone Furoate Ointment, 0.1% should not be used in the treatment of diaper dermatitis.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical trials of mometasone furoate ointment, 0.1% included 310 subjects who were 65 years of age and over and 57 subjects who were 75 years of age 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 subjects. However, greater sensitivity of some older individuals cannot be ruled out.
🆘 Overdosage ▾
10 OVERDOSAGE Topically applied Mometasone Furoate Ointment, 0.1% can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.
It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 .
12.2Pharmacodynamics Studies performed with mometasone furoate ointment, 0.1% indicate that it is in the medium range of potency as compared with other topical corticosteroids. In a study evaluating the effects of mometasone furoate ointment on the HPA axis, 15 grams were applied twice daily for 7 days to 6 adult subjects with psoriasis or atopic dermatitis. The ointment was applied without occlusion to at least 30% of the body surface.
The results showed that the drug caused a slight lowering of adrenal corticosteroid secretion [see Warnings and Precautions (5.1)] . Sixty-three pediatric subjects ages 6 to 23 months, with atopic dermatitis, were enrolled in an open-label HPA axis safety study. Mometasone furoate ointment, 0.1% was applied once daily for approximately 3 weeks over a mean body surface area of 39% (range 15%-99%).
In approximately 27% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with mometasone furoate ointment, 0.1%. The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 3 subjects, using these same criteria [see Use in Specific Populations (8.4)] .
12.3Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0.7% of the applied dose of mometasone furoate ointment, 0.1% enters the circulation after 8 hours of contact on normal skin without occlusion. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.
It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Mometasone Furoate Ointment USP, 0.1% is a white to off-white uniform ointment and supplied in 45-gram (NDC 63629-9306) tubes; boxes of one. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
11 DESCRIPTION Mometasone Furoate Ointment USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27 H 30 Cl 2 O 6 , a molecular weight of 521.4 and the following structural formula: Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.
Each gram of Mometasone Furoate Ointment USP, 0.1% contains 1 mg mometasone furoate in a white to off-white uniform ointment base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), purified water, white wax, and white petrolatum.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following: • Use Mometasone Furoate Ointment, 0.1% as directed by the physician. It is for external use only. • Avoid contact with the eyes. • Advise patients to report any visual symptoms to their healthcare providers. • Do not use Mometasone Furoate Ointment, 0.1% on the face, underarms, or groin areas. • Do not use Mometasone Furoate Ointment, 0.1% for any disorder other than that for which it was prescribed. • Do not bandage or otherwise cover or wrap the treated area so as to be occlusive, unless directed by the physician. • Report any signs of local adverse reactions to the physician. • Advise patients not to use Mometasone Furoate Ointment, 0.1% in the treatment of diaper dermatitis.
Do not apply Mometasone Furoate Ointment, 0.1% in the diaper area, as diapers or plastic pants may constitute occlusive dressing. • Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician. • Do not use other corticosteroid-containing products with Mometasone Furoate Ointment, 0.1% without first consulting with the physician.
💬 Patient Medication Information ▾
Patient Information Mometasone Furoate (moe-MET-a-sone fur-o-ate) Ointment USP, 0.1% Important information: Mometasone Furoate Ointment, 0.1% is for use on skin only. Do not use Mometasone Furoate Ointment, 0.1% in your eyes, mouth, or vagina. What is Mometasone Furoate Ointment, 0.1%? • Mometasone Furoate Ointment, 0.1% is a prescription medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 2 years of age and older. • It is not known if Mometasone Furoate Ointment, 0.1% is safe and effective for use in children under 2 years of age. • Mometasone Furoate Ointment, 0.1% should not be used in children under 2 years of age. • It is not known if Mometasone Furoate Ointment, 0.1% is safe and effective for use in children longer than 3 weeks.
Do not use Mometasone Furoate Ointment, 0.1% if you are allergic to mometasone furoate or any of the ingredients in Mometasone Furoate Ointment, 0.1%. See the end of this leaflet for a complete list of ingredients in Mometasone Furoate Ointment, 0.1%. Before using Mometasone Furoate Ointment, 0.1%, tell your healthcare provider about all your medical conditions, including if you: • have a skin infection at the site to be treated.
You may also need medicine to treat the skin infection. • are pregnant or plan to become pregnant. It is not known if Mometasone Furoate Ointment, 0.1% will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if Mometasone Furoate Ointment, 0.1% passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids. How should I use Mometasone Furoate Ointment, 0.1%? • Use Mometasone Furoate Ointment, 0.1% exactly as your healthcare provider tells you to use it. • Apply a thin film of Mometasone Furoate Ointment, 0.1% to the affected skin area 1 time each day. • Use Mometasone Furoate Ointment, 0.1% until the affected skin area is improved.
Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment. • Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to. • Mometasone Furoate Ointment, 0.1% should not be used to treat diaper rash or redness. Do not apply Mometasone Furoate Ointment, 0.1% in the diaper area if wearing diapers or plastic pants. • Avoid using Mometasone Furoate Ointment, 0.1% on the face, groin, or underarms (armpits). • Wash your hands after applying Mometasone Furoate Ointment, 0.1%.
What are the possible side effects of Mometasone Furoate Ointment, 0.1%? Mometasone Furoate Ointment, 0.1% may cause serious side effects, including: • Mometasone Furoate Ointment, 0.1% can pass through your skin. Too much Mometasone Furoate Ointment, 0.1% passing through your skin can cause your adrenal glands to stop working properly.
Your healthcare provider may do blood tests to check for adrenal gland problems. • Vision problems. Topical corticosteroids may increase your chance of developing vision problems such as cataract and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with Mometasone Furoate Ointment, 0.1%. • Skin problems.
Skin problems may happen during treatment with Mometasone Furoate Ointment, 0.1%, including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using Mometasone Furoate Ointment, 0.1% and tell your healthcare provider if you develop any skin reactions such as pain, tenderness, swelling, or problems healing during treatment with Mometasone Furoate Ointment, 0.1%. The most common side effects of Mometasone Furoate Ointment, 0.1% include burning, itching, thinni…