Mometasone Furoate 1 mg/g Ointment — NDC 0713-0635-37 (Billing 00713-0635-37)
This is a package of Mometasone Furoate 1 mg/g Ointment from Cosette Pharmaceuticals, Inc., marketed since Mar 2014 and currently FDA-listed; retail pharmacies pay about $0.2077 per g (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0713-0635-37 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0713 labeler · 0635 product · 37 package
- Package marketed since
- Mar 4, 2014
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0713063537 0
- Medicaid fills, this package
- 48,418 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Mometasone Furoate (different manufacturers) — 2 · tap to view
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): 007639
- GCN: 45930
- GPI-14 (Medi-Span): 90550082104210
- HICL (First Databank): 003329
- AHFS class code: 48:10.08.00
- RxCUI (RxNorm): 151029
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the product. The nasal spray treats hay fever symptoms and nasal polyps, Asmanex inhalers treat asthma long term, Sinuva treats nasal polyps after sinus surgery, and...
- No. Asmanex is for daily control, not quick relief. Use your fast-acting rescue inhaler, and call your doctor if your asthma isn't responding.
- Can I use my Asmanex inhaler during an asthma attack?
- Inhaled steroids can cause thrush, a yeast infection in the mouth and throat. Rinse with water and spit it out, without swallowing, after every dose.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Mometasone Furoate — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 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 | $0.208 | $9.35 / 45 g |
| Medicaid paysCMS SDUD · 12 mo | $0.4232 | $19.04 / 45 g |
| Medicare drug plans payPart D · Q2 2026 | $0.3780 | $17.01 / 45 g |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 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 | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00713-0635-15 0713-0635-15 | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | $0.2922 / g | $4.38 | 2014-03-04 | — | Active |
| 00713-0635-37 You're viewing this Main listing | 1 TUBE in 1 CARTON / 45 g in 1 TUBE | $0.2077 / g | $9.35 | 2014-03-04 | — | Active |
This pack has the lowest per-g cost of the 2 priced pack sizes ($0.2077 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 63% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Mometasone Furoate 1 mg/g Ointment?
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mometasone Furoate 1 mg/gthis 00713-0635-37 | Cosette | 1 tube | $0.208 | AB | Availability likely | — |
| Mometasone Furoate 1 mg 13668-0527-01 | Torrent | 15 ointments | $0.292 | AB | Availability likely | +41% |
| Mometasone Furoate 1 mg/g 45802-0119-37 | Padagis | 1 tube | $0.292 | AB | Availability likely | +41% |
| Mometasone Furoate 1 mg/g 68462-0225-17 | Glenmark | 15 g | $0.351 | — | Discontinued | +69% |
| Mometasone Furoate 1 mg/g 00713-0634-15 | Cosette | 1 tube | $0.420 | AB | Availability likely | +102% |
| Mometasone Furoate 1 mg/g 45802-0257-35 | Padagis | 1 tube | $0.420 | AB | Availability likely | +102% |
| Mometasone Furoate 1 mg/g 68462-0192-17 | Glenmark | 15 g | $0.483 | — | FDA listed | +132% |
| 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/g 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?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 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 Mometasone 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 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 4T6H12BN9U
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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UNII E4GA8884NN
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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UNII MZM1I680W0
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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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.
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UNII 7G1J5DA97F
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 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 Cosette Pharmaceuticals, Inc. labeler code 00713
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- Fluticasone Propionate .5 mg/g Cream NDC 0713-0631-15
- Fluticasone Propionate .05 mg/g Ointment NDC 0713-0632-15
- Metronidazole 7.5 mg/g Cream NDC 0713-0633-37
- Mometasone Furoate 1 mg/g Cream NDC 0713-0634-15
- Metronidazole 7.5 mg/g Gel NDC 0713-0637-37
- Ciclopirox Olamine 7.7 mg/g Cream NDC 0713-0638-15
- Halobetasol Propionate .5 mg/g Cream NDC 0713-0640-15
- Triamcinolone Acetonide 1 mg/g Paste NDC 0713-0655-40
- Clobetasol Propionate .5 mg/g Ointment NDC 0713-0656-15
- Betamethasone Dipropionate .5 mg/g Cream NDC 0713-0659-15
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Mometasone furoate, USP 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, USP 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. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply a thin film of mometasone furoate, USP 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, USP ointment 0.1% with occlusive dressings unless directed by a physician. Do not apply mometasone furoate, USP 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, USP 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, USP 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, USP ointment 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. • Mometasone furoate, USP ointment 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. ( 4 )
⚠️ 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 furoate, USP 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, USP 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, USP 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 Cosette Pharmaceuticals, Inc. at 1-800-922-1038 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, USP 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, USP ointment 0.1%have been reported. The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate, USP 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, USP 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 dressing Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.
To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with mometasone furoate, USP 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, USP 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, USP 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, USP 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, USP 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, USP 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, USP 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, USP ointment 0.1% is administered to a nursing woman.
8.4Pediatric Use Mometasone furoate, USP 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, USP 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, USP 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 tre… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate, USP 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, USP 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, USP 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, USP 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, USP 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, USP 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, USP ointment 0.1% is administered to a nursing woman.
8.4Pediatric Use Mometasone furoate, USP 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, USP 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, USP 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… [Excerpted — this section continues on DailyMed.]
🆘 Overdosage ▾
10 OVERDOSAGE Topically applied mometasone furoate, USP 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, USP 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, USP 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, USP 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, USP 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, USP ointment 0.1% is supplied in 15 gram (NDC 0713-0635-15) and 45 gram (NDC 0713-0635-37) tubes; boxes of one. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Mometasone furoate, USP ointment 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, USP ointment 0.1% contains 1 mg mometasone furoate in an ointment base of hexylene glycol, phosphoric acid, propylene glycol stearate, purified water, white wax, and white petrolatum. Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Inform the patients of the following: • Use mometasone furoate, USP 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, USP ointment 0.1% on the face, underarms, or groin areas. • Do not use mometasone furoate, USP ointment 0.1% for any disorder other than that for which it was prescribed. • Do not bandage or otherwise cover or wrap the treated skin 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, USP ointment 0.1% in the treatment of diaper dermatitis.
Do not apply mometasone furoate, USP 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, USP ointment 0.1% without first consulting with the physician. Distributed by: Cosette Pharmaceuticals, Inc.
South Plainfield, NJ 07080 8-0635CPLNC3 Rev. 03/2022 VC7622
🧬 Pharmacokinetics ▾
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, USP 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.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Studies performed with mometasone furoate, USP 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, USP 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, USP 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 )].
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The safety and efficacy of mometasone furoate, USP ointment 0.1% for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle-controlled trials, one in psoriasis and one in atopic dermatitis. A total of 218 subjects received mometasone furoate, USP ointment 0.1% (109 subjects) or the vehicle ointment applied once daily for 21 days.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate, USP ointment 0.1%. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate, USP ointment 0.1% on a mcg/m 2 basis).
In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate, USP ointment 0.1% on a mcg/m 2 basis). Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vitro mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay.
Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes. In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate, USP ointment 0.1% on a mcg/m 2 basis).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate, USP ointment 0.1%. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate, USP ointment 0.1% on a mcg/m 2 basis).
In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate, USP ointment 0.1% on a mcg/m 2 basis). Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vitro mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay.
Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes. In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate, USP ointment 0.1% on a mcg/m 2 basis).
📄 Patient Package Insert ▾
Patient Information Mometasone Furoate, USP Ointment 0.1% (Mo-meta-sone fur-o-ate) Important information: Mometasone furoate, USP ointment 0.1% is for use on skin only. Do not use mometasone furoate, USP ointment 0.1% in your eyes, mouth, or vagina. What is mometasone furoate, USP ointment 0.1%? • Mometasone furoate, USP 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, USP ointment 0.1% is safe and effective for use in children under 2 years of age. • Mometasone furoate, USP ointment 0.1% should not be used in children under 2 years of age. • It is not known if mometasone furoate, USP ointment 0.1% is safe and effective for use in children longer than 3 weeks.
Do not use mometasone furoate, USP ointment 0.1% if you are allergic to mometasone furoate or any of the ingredients in mometasone furoate, USP ointment 0.1%. See the end of this leaflet for a complete list of ingredients in mometasone furoate, USP ointment 0.1%. Before using mometasone furoate, USP 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, USP ointment 0.1% will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if mometasone furoate, USP 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, USP ointment 0.1%? • Use mometasone furoate, USP ointment 0.1% exactly as your healthcare provider tells you to use it. • Apply a thin film of mometasone furoate, USP ointment 0.1% to the affected skin area 1 time each day. • Use mometasone furoate, USP 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, USP ointment 0.1% should not be used to treat diaper rash or redness. Do not apply mometasone furoate, USP ointment 0.1% in the diaper area if wearing diapers or plastic pants. • Avoid using mometasone furoate, USP ointment 0.1% on the face, groin, or underarms (armpits). • Wash your hands after applying mometasone furoate, USP ointment 0.1%.
What are the possible side effects of mometasone furoate, USP ointment 0.1%? Mometasone furoate, USP ointment 0.1% may cause serious side effects, including: • Mometasone furoate, USP ointment 0.1% can pass through your skin. Too much mometasone furoate, USP 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, USP ointment 0.1%. • Skin problems.
Skin problems may happen during treatment with mometasone furoate, USP ointment 0.1%, including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using mometasone furoate, USP 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, US… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Warnings and Precautions Ophthalmic Adverse Reactions ( 5.2 ) 05/2018
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 0713-0635-15 Mometasone Furoate, USP Ointment 0.1% 15 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0635-37 Mometasone Furoate, USP Ointment 0.1% 45 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. 15gm-carton 45gm-carton