Mometasone Furoate 1 mg Ointment, 15-count — NDC 13668-527-01 (Billing 13668-0527-01)
This is a package of 15 ointments of Mometasone Furoate 1 mg Ointment from Torrent Pharmaceuticals Limited, marketed since Dec 2024 and currently FDA-listed; retail pharmacies pay about $0.2922 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 13668-527-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 13668 labeler · 527 product · 01 package
- Package marketed since
- Dec 15, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0313668527018
- FDA record last changed
- Aug 27, 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
- 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 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 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 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 | $0.292 | — |
| 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 | — |
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 · refreshed Oct 8, 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 |
|---|---|---|---|---|---|---|
| 13668-0527-01 You're viewing this Main listing | 15 OINTMENT in 1 BOX | $0.2922 / g | — | 2018-07-13 | — | Active |
| 13668-0527-04 13668-527-04 | 45 OINTMENT in 1 BOX | $0.2077 / g | — | 2018-07-13 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
Per g, this pack runs about 41% above the cheapest pack (45-count, $0.2077 vs $0.2922 NADAC).
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 13668-0527-04?
What NDC number is used to bill for this package of Mometasone Furoate 1 mg 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/g 00713-0635-15 | Cosette | 1 tube | $0.292 | AB | Availability likely | — |
| Mometasone Furoate 1 mgthis 13668-0527-01 | Torrent | 15 ointments | $0.292 | AB | Availability likely | — |
| Mometasone Furoate 1 mg/g 45802-0119-37 | Padagis | 1 tube | $0.292 | AB | Availability likely | — |
| Mometasone Furoate 1 mg/g 68462-0225-17 | Glenmark | 15 g | $0.351 | — | Discontinued | +20% |
| 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 | — |
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 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 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 Torrent Pharmaceuticals Limited labeler code 13668
- Minocycline Hydrochloride 100 mg Capsule NDC 13668-484-05
- Minocycline Hydrochloride 50 mg Tablet NDC 13668-485-01
- Minocycline Hydrochloride 75 mg Tablet NDC 13668-486-01
- Minocycline Hydrochloride 100 mg Tablet NDC 13668-487-50
- Lurasidone hydrochloride 60 mg Tablet, Film Coated NDC 13668-509-30
- acyclovir 50 mg/g Ointment NDC 13668-515-01
- Montelukast Sodium 4 mg/500mg Granule NDC 13668-531-94
- Nystatin 100000 U/g Ointment NDC 13668-534-01
- Eslicarbazepine acetate 200 mg Tablet NDC 13668-538-05
- Eslicarbazepine acetate 400 mg Tablet NDC 13668-539-05
- Eslicarbazepine acetate 600 mg Tablet NDC 13668-540-05
- Eslicarbazepine acetate 800 mg Tablet NDC 13668-541-05
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 Mometasone furoate ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults and pediatric patients 2 years of age and older. ( 1 ) Mometasone furoate ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults and pediatric patients 2 years of age or older.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For topical use only. Not for oral, ophthalmic, or intravaginal use. (2) 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 occlusion.
(2) Mometasone furoate ointment is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Apply a thin film of mometasone furoate ointment to the affected skin areas once daily.
Avoid use on the face, groin, or axillae. Wash hands after each application. Avoid contact with eyes [see Warnings and Precautions ( 5.2 )].
Do not use mometasone furoate ointment with occlusion. Do not use mometasone furoate ointment in the treatment of diaper dermatitis. Discontinue therapy when control is achieved.
If no improvement is seen within 2 weeks, consider reassessment of diagnosis [see Warnings and Precautions ( 5.1 )].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ointment, 0.1%. Ointment, 0.1%. Each gram of mometasone furoate ointment, USP contains 1 mg of mometasone furoate USP in a white to off-white uniform ointment base.
⛔ Contraindications ▾
4 CONTRAINDICATIONS Mometasone furoate ointment is contraindicated in patients with a history of hypersensitivity to mometasone furoate or any of the excipients in mometasone furoate ointment. ( 4 ) Mometasone furoate ointment is contraindicated in patients with a history of hypersensitivity to mometasone furoate or any of the excipients in mometasone furoate ointment.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Endocrine System Adverse Reactions: o Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur with the potential for glucocorticosteroid insufficiency. ( 5.1 ) o Consider periodic evaluations for HPA axis suppression if mometasone furoate ointment is applied to a large surface area, to areas under occlusion, for prolonged duration or on altered skin barriers. If HPA axis suppression occurs, withdraw mometasone furoate ointment, reduce the application frequency, or consider switching to a less potent corticosteroid.
( 5.1 , 8.4 ) o Cushing’s syndrome, hyperglycemia, and glucosuria may occur due to systemic absorption. ( 5.1 , 8.4 ) o Pediatric patients may be more susceptible to systemic toxicity. ( 5.1 , 8.4 ) Ophthalmic Adverse Reactions: Topical corticosteroids may increase the risk of cataracts and glaucoma.
If visual symptoms occur, consider referral to an ophthalmologist. ( 5.2 )
5.1Endocrine System Adverse Reactions Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression Systemic absorption of topical corticosteroids, including mometasone furoate ointment, can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high-potency corticosteroids, 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, consider periodically evaluating patients who are at risk of HPA axis suppression for evidence of HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a trial 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.
In this trial, mometasone furoate ointment caused a slight lowering of adrenal corticosteroid secretion [see Clinical Pharmacology ( 12.2 )] . If HPA axis suppression occurs, gradually withdraw mometasone furoate ointment, reduce the frequency of application or consider use of a less potent corticosteroid. If signs and symptoms of glucocorticosteroid insufficiency occur, supplemental systemic corticosteroids may be required.
Cushing’s Syndrome, Hyperglycemia, and Glucosuria Systemic effects of topical corticosteroids, including mometasone furoate ointment, may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. Additional Considerations Concomitant use of mometasone furoate ointment with other corticosteroid-containing products may increase total systemic corticosteroid exposure, and result in increased risk for adverse reactions. 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 )] .
Minimize the risk of adverse reactions by using mometasone furoate ointment as recommended [see Dosage and Administration ( 2 )] .
5.2Ophthalmic Adverse Reactions Use of topical corticosteroids, including mometasone furoate ointment, 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 topical mometasone products [see Adverse Reactions ( 6.2 )] Avoid contact of mometasone furoate ointment with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
5.3Allergic Contact Dermatitis Use of topical corticosteroids, including mometasone furoate ointment, can cause allergic contact dermatitis. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacer… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions are burning, pruritus, skin atrophy, tingling/stinging and furunculosis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc., at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions are discussed in more detail in other sections of the labeling: • Endocrine System Adverse Reactions [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] • Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Allergic Contact Dermatitis [see Warnings and Precautions ( 5.3 )] • Concomitant Skin infections [see Warnings and Precautions ( 5.4 )]
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 the incidence of adverse reactions associated with the use of mometasone furoate ointment 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 have been reported.
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of topical corticosteroids. 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. Endocrine Disorders: Cushing’s syndrome, linear growth retardation, and delayed weight gain.
Local Adverse Reactions: irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, striae, and miliaria. Nervous System Disorders: intracranial hypertension. Ophthalmic Adverse Reactions: blurred vision, cataracts, glaucoma, and increased intraocular pressure.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women. Available data from postmarketing reports and published observational studies over decades of use with mometasone furoate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes. Maternal use of potent or very potent topical corticosteroids may be associated with an increased risk of low birth weight infants (see Data) .
Advise pregnant women to use mometasone furoate ointment on the smallest area of skin and for the shortest duration possible. When administered subcutaneously, orally, or topically 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 (see Data) . The available data do not allow the calculation of relevant comparisons between the systemic exposure of mometasone furoate observed in animal studies to the systemic exposure that would be expected in humans after topical use of mometasone furoate ointment. 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Published data from one observational study that included 60,497 pregnancies exposed to topical corticosteroids, including 10,056 pregnancies exposed to topical mometasone, did not identify an increased risk of low birth weight infants.
However, data from other observational studies demonstrate that maternal use of potent to very potent topical corticosteroids was associated with an increased risk of low birth weight infants, especially when the cumulative dosage throughout pregnancy was greater than 300 grams. Available studies have limitations including confounding by disease severity, imprecision in birth weight outcomes, and data reliance on filled prescriptions rather than actual use. Animal Data 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. In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above.
Mometasone furoate produced delays in ossification, but no malformations at 300 mcg/kg. 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. 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. When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival were observed at 15 mcg/kg.
Similar effects were not observed at 7.5 mcg/kg.
8.2Lactation Risk Summary There are no data on the presence of mometasone furoate following topical administration in animal or human milk, the effects on the breastfed infant, or the effects on milk production. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. To minimize potential exposure to the breastfed infant via breast milk, use mometasone furoate ointment on the smallest area of skin… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women. Available data from postmarketing reports and published observational studies over decades of use with mometasone furoate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes. Maternal use of potent or very potent topical corticosteroids may be associated with an increased risk of low birth weight infants (see Data) .
Advise pregnant women to use mometasone furoate ointment on the smallest area of skin and for the shortest duration possible. When administered subcutaneously, orally, or topically 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 (see Data) . The available data do not allow the calculation of relevant comparisons between the systemic exposure of mometasone furoate observed in animal studies to the systemic exposure that would be expected in humans after topical use of mometasone furoate ointment. 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Published data from one observational study that included 60,497 pregnancies exposed to topical corticosteroids, including 10,056 pregnancies exposed to topical mometasone, did not identify an increased risk of low birth weight infants.
However, data from other observational studies demonstrate that maternal use of potent to very potent topical corticosteroids was associated with an increased risk of low birth weight infants, especially when the cumulative dosage throughout pregnancy was greater than 300 grams. Available studies have limitations including confounding by disease severity, imprecision in birth weight outcomes, and data reliance on filled prescriptions rather than actual use. Animal Data 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. In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above.
Mometasone furoate produced delays in ossification, but no malformations at 300 mcg/kg. 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. 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. When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival were observed at 15 mcg/kg.
Similar effects were not observed at 7.5 mcg/kg.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of mometasone furoate ointment for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses have been established in pediatric patients 2 years of age or older [see Adverse Reactions ( 6.1 )] . The safety and efficacy of mometasone furoate ointment have not been established in pediatric patients younger than 2 years of age. The safety and efficacy of mometasone furoate ointment use for longer than three weeks have not been established in pediatric patients 2 years of age and older.
The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate ointment 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 in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; and thinness, 1.
Endocrine Adverse Reactions Sixty-three pediatric subjects ages 6 to 23 months, with atopic dermatitis, were enrolled in an open-label HPA axis safety trial. Mometasone furoate ointment 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 applied mometasone furoate ointment 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. Mometasone furoate ointment is not indicated for use in pediatric patients younger than 2 years of age [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. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids.
Manifestations of adrenal suppression in pediatrics include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Do not use mometasone furoate ointment in the treatment of diaper dermatitis.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical trials of mometasone furoate ointment 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, but greater sensitivity of some older individuals cannot be ruled out.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in dermatoses is unknown.
12.2Pharmacodynamics Studies performed with mometasone furoate ointment indicate that it is in the medium range of potency as compared with other topical corticosteroids. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression 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 was applied once daily 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. 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 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 Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in dermatoses is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Mometasone furoate ointment, USP 0.1% is a white to off-white uniform ointment and supplied in 15-gram (NDC 13668-527-01) and 45-gram (NDC 13668-527-04) tubes; boxes of one. Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Mometasone furoate ointment, USP 0.1% contains 1 mg mometasone furoate, USP per gram in a white to off-white uniform ointment base for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate, USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula: Mometasone furoate, USP is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.
Mometasone furoate ointment, USP 0.1% contains the following inactive ingredients: hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), purified water, white petrolatum, and white wax. structure
🧬 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 ointment 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 ointment indicate that it is in the medium range of potency as compared with other topical corticosteroids. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression 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 was applied once daily 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. 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 ointment, 0.1% for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle-controlled trials, one in subjects with psoriasis and one in subjects with atopic dermatitis. These trials included a total of 218 subjects with 109 subjects applying mometasone furoate ointment and 109 subjects applying vehicle ointment 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 ointment. 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.
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. 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 vivo 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, mometasone furoate did not cause impairment of fertility in male or female rats at subcutaneous doses up to 15 mcg/kg.
📄 Patient Package Insert ▾
Patient Information Mometasone furoate (moe—MET—a—sone-FYOOR-oh-ate) ointment, USP 0.1% Important information: Mometasone furoate ointment is for use on skin only (topical). Do not use mometasone furoate ointment in your eyes, mouth, or vagina. W hat is mometasone furoate ointment ?
Mometasone furoate ointment 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 adults and children 2 years of age or older. It is not known if mometasone furoate ointment is safe and effective for use in children under 2 years of age. Mometasone furoate ointment is not recommended for use in children under 2 years of age.
Do not use mometasone furoate ointment if you: are allergic to mometasone furoate or any of the ingredients in mometasone furoate ointment. See the end of this leaflet for a complete list of ingredients in mometasone furoate ointment. Before using mometasone furoate ointment , tell your healthcare provider about all your medical conditions, including if you: have had irritation or other skin reaction to a steroid medicine in the past. have a skin infection at the site to be treated.
You may need medicine to treat the skin infection before using mometasone furoate ointment. have thinning of the skin (atrophy) at the treatment site. have diabetes. have adrenal gland problems. have liver problems. are pregnant or plan to become pregnant. It is not known if mometasone furoate ointment will harm your unborn baby. If you use mometasone furoate ointment during pregnancy, use mometasone furoate ointment on the smallest area of the skin and for the shortest time needed. are breastfeeding or plan to breastfeed.
It is not known if mometasone furoate passes into your breast milk. If you use mometasone furoate ointment and breastfeed, use mometasone furoate ointment on the smallest area of the skin and for the shortest time needed. Do not apply mometasone furoate ointment directly to the nipple and areola to avoid contact with your baby.
T el l 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. Do not use other products containing a corticosteroid medicine while using mometasone furoate ointment without talking to your healthcare provider first.
How should I use mometasone furoate ointment ? Use mometasone furoate ointment exactly as your healthcare provider tells you to use it. Apply a thin film of mometasone furoate ointment to the affected skin area 1 time each day.
Use mometasone furoate ointment 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 should not be used to treat diaper rash or redness. Do not apply mometasone furoate ointment in the diaper area if wearing diapers or plastic pants. Avoid using mometasone furoate ointment on the face, groin, or underarms (armpits).
Wash your hands after applying mometasone furoate ointment. W hat are the possible side effects of mometasone furoate ointment ? Mometasone furoate ointment may cause serious side effects, including: Mometasone furoate ointment ca n pass through your skin.
Too much mometasone furoate ointment 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. Cushing’s syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol.
High blood sugar (hyperglycemia). Effects on growth and weight in children. Vision problems.
Topical corticosteroids, includi… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Mometasone Furoate 15 gm tube Mometasone Furoate 15 gm carton tube carton