Hydrocortisone Butyrate 1 mg/mL Lotion — NDC 68180-951-02 (Billing 68180-0951-02)
This is a package of Hydrocortisone Butyrate 1 mg/mL Lotion from Lupin Pharmaceuticals, Inc., marketed since Aug 2018 and currently FDA-listed; retail pharmacies pay about $0.7000 per mL (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 68180-951-02 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 68180 labeler · 951 product · 02 package
- Package marketed since
- Aug 17, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 6818095102 5
- Medicaid fills, this package
- 1,063 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 018275
- GCN: 62480
- GPI-14 (Medi-Span): 90550075304120
- HICL (First Databank): 003297
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 1370763
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone 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 ↗- It calms redness, swelling and itching from skin conditions that respond to steroids. Hydrocortisone Butyrate Cream (lipid), 0.1% is used in adults for those conditions. It is also...
- Apply it to your skin exactly as your prescriber and the label direct. In the studies it was used twice a day for mild to moderate eczema. Keep it out of your eyes, and don't cover...
- Most are mild and happen where you apply it. These include irritation, burning, itching, dryness, acne or inflamed hair follicles. With longer use, skin thinning or stretch marks c...
- Call if you notice blurred vision or other eye changes, if your skin looks infected, or if the rash gets worse or won't heal. Also call about signs the steroid is affecting your wh...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.700 | $82.60 / 118 ml |
| Medicaid paysCMS SDUD · 12 mo | $1.40 | $164.67 / 118 ml |
| Medicare drug plans payPart D · Q2 2026 | $3.76 | $443.43 / 118 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 68180-0951-01 68180-951-01 | 1 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE | — | — | 2018-08-17 | — | Active |
| 68180-0951-02 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE | $0.7000 / mL | $82.59 | 2018-08-17 | — | Active |
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 Hydrocortisone Butyrate 1 mg/mL Lotion?
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 |
|---|---|---|---|---|---|---|
| Hydrocortisone Butyrate 1 mg/mLthis 68180-0951-02 | Lupin | 1 bottle | $0.700 | AB | Availability likely | — |
| Hydrocortisone Butyrate 1 mg/mL 68682-0392-02 | Oceanside | 1 bottle | — | — | Discontinued | — |
| Hydrocortisone Butyrate 1 mg/mL 72162-2630-02 | Bryant | 1 bottle | — | AB | FDA listed | — |
| Hydrocortisone Butyrate 1 mg/mL 83148-0012-02 | The | 1 bottle | — | AB | FDA listed | — |
| Evesse 1 mg/mL 87143-0420-04 | Perfero | 118 ml | — | 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
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 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 Hydrocortisone Topical 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 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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UNII 3QPI1U3FV8
A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
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UNII I835H2IHHX
A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
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UNII 2DMT128M1S
A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
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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 Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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UNII 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.
10 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 8, 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 Lupin Pharmaceuticals, Inc. labeler code 68180
- Desoximetasone 2.5 mg/mL Spray NDC 68180-944-11
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- Betamethasone dipropionate .5 mg/g Ointment, Augmented NDC 68180-947-01
- Desoximetasone .5 mg/g Ointment NDC 68180-948-01
- Desoximetasone .5 mg/g Cream NDC 68180-949-01
- Desoximetasone 2.5 mg/g Cream NDC 68180-950-01
- Hydrocortisone Valerate 2 mg/g Cream NDC 68180-954-01
- Clobetasol Propionate .5 mg/g Cream NDC 68180-956-01
- Tobramycin 300 mg/5mL Solution NDC 68180-962-56
- Albuterol sulfate 90 ug Aerosol, Metered NDC 68180-963-01
- Tiotropium Bromide 18 ug Capsule NDC 68180-964-12
- Levothyroxine Sodium .025 mg Tablet NDC 68180-965-01
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 Hydrocortisone butyrate lotion, 0.1% is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Hydrocortisone butyrate lotion, 0.1% is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply a thin layer to the affected skin areas two times daily, and rub in gently. Do not apply hydrocortisone butyrate lotion, 0.1% in the diaper area unless directed by a physician. Discontinue therapy when control is achieved.
If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse events. The safety and efficacy of hydrocortisone butyrate lotion, 0.1% has not been established beyond 4 weeks of use [see WARNINGS AND PRECAUTIONS (5.1) ] .
Do not use hydrocortisone butyrate lotion, 0.1% with occlusive dressings unless directed by a physician. Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings. Hydrocortisone butyrate lotion, 0.1% is not for oral, ophthalmic, or intravaginal use.
Apply a thin layer to the affected skin two times daily. ( 2 ) Rub in gently. ( 2 ) Discontinue hydrocortisone butyrate lotion, 0.1% when control is achieved.
( 2 ) Reassess diagnosis if no improvement is seen within 2 weeks. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse events. Safety and efficacy of hydrocortisone butyrate lotion, 0.1% has not been established beyond 4 weeks of use.
( 2 ) Avoid use under occlusion or in the diaper area. ( 2 ) Hydrocortisone butyrate lotion, 0.1% is not for oral, ophthalmic, or intravaginal use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Lotion, 0.1%. Each gram of hydrocortisone butyrate lotion, 0.1% contains 1 mg of hydrocortisone butyrate USP in a white to off white lotion base. Hydrocortisone butyrate lotion, 0.1% is supplied in bottles of 2 fl. oz. and 4 fl. oz. Lotion, 0.1% (1 mg/g), supplied in bottles of 2 fl. oz. and 4 fl. oz. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency. Consider periodic evaluations for HPA axis suppression if hydrocortisone butyrate lotion is applied to large surface areas or used under occlusion. If HPA axis suppression is noted, reduce the application frequency, discontinue use, or switch to a lower potency corticosteroid.
( 5.1 , 8.4 ) Systemic effects of topical corticosteroids may also include manifestations of Cushing's syndrome, hyperglycemia, and glucosuria. ( 5.1 , 8.4 ) Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface-to-body-mass ratios. ( 5.1 , 8.4 ) Initiate appropriate therapy if concomitant skin infections develop.
( 5.2 )
5.1Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression Systemic effects of topical corticosteroids may include reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria. Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of hydrocortisone butyrate lotion. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of hydrocortisone butyrate lotion due to their larger skin surface-to-body mass ratios [ see USE IN SPECIFIC POPULATIONS (8.4) ].
Patients applying a topical corticosteroid to a large surface area or to areas under occlusion should be considered for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH 1 to 24 ) stimulation testing (CST). Minimize systemic corticosteroid effects by mitigating the risk factors for increased systemic absorption and using hydrocortisone butyrate lotion as recommended [ see DOSAGE AND ADMINISTRATION (2) ].
If HPA axis suppression is noted, the frequency of application should be reduced or the drug should be withdrawn, or a less potent corticosteroid should be substituted. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids [see ADVERSE REACTIONS (6) ].
5.2Concomitant Skin Infections If skin infections are present or develop, an appropriate antifungal, antibacterial or antiviral agent should be used. If a favorable response does not occur promptly, use of hydrocortisone butyrate lotion should be discontinued until the infection has been adequately controlled [see ADVERSE REACTIONS (6) ].
5.3Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate patch testing. Discontinue hydrocortisone butyrate lotion if the diagnosis is established [see ADVERSE REACTIONS (6) ].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: HPA axis suppression. This has been observed in pediatric subjects using hydrocortisone butyrate lotion [ see WARNINGS AND PRECAUTIONS (5.1) and USE IN SPECIFIC POPULATIONS (8.4) ] Concomitant skin infections [see WARNINGS AND PRECAUTIONS (5.2) ] Allergic contact dermatitis [ see WARNINGS AND PRECAUTIONS (5.3) ] The most common adverse reactions (>1%) are application site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 and/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, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. The safety data derived from hydrocortisone butyrate lotion clinical trials reflect exposure to hydrocortisone butyrate lotion twice daily for up to four weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age and adult subjects 18 years of age and older with mild to moderate atopic dermatitis.
Adverse reactions shown in the tables below include those for which there is some basis to believe there is a causal relationship to hydrocortisone butyrate lotion. Although the rates of application site reactions in the vehicle group were greater than those in the hydrocortisone butyrate lotion group in both studies, these rates are included in the tables (Table 1 and Table 2) because skin irritation is a known adverse reaction of topical corticosteroids. TABLE 1.
Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis Hydrocortisone Butyrate Lotion ( n=139) n (%) Vehicle ( n=145) n (%) Application site reactions, including application site burning, pruritus, dermatitis, erythema, eczema, inflammation, or irritation 2 (1) 20 (14) Infantile acne 1 (1) 0 (0) Skin depigmentation 1 (1) 0 (0) TABLE 2. Frequency of adverse reactions in adult subjects with mild to moderate atopic dermatitis Hydrocortisone Butyrate Lotion ( n=151) n (%) Vehicle ( n=150) n (%) Application site reactions, including application site burning, dermatitis, eczema, erythema, or pruritus 5 (3) 7 (5)
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. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions included: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria and telangiectasia.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Therefore, hydrocortisone butyrate lotion 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. Note: The animal multiples of human exposure calculations in this label were based on body surface area comparisons for an adult (i.e., mg/m 2 /day dose comparisons) assuming 100% human percutaneous absorption of a maximum topical human dose (MTHD) for hydrocortisone butyrate lotion (25 g lotion).
Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses of 0.6, 1.8 and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 6 to 17. In the presence of maternal toxicity, fetal effects noted at 5.4 mg/kg/day (2X MTHD) included an increased incidence of ossification variations and unossified sternebra.
No treatment-related effects on embryofetal toxicity or teratogenicity were noted at doses of 5.4 mg/kg/day and 1.8 mg/kg/day, respectively (2X MTHD and 0.7X MTHD, respectively). Subcutaneous doses of 0.1, 0.2 and 0.3 mg/kg/day hydrocortisone butyrate were administered to pregnant female rabbits during gestation days 7 to 20. An increased incidence of abortion was noted at 0.3 mg/kg/day (0.2X MTHD).
In the absence of maternal toxicity, a dose-dependent decrease in fetal body weight was noted at doses ≥0.1 mg/kg/day (0.1X MTHD). Additional indicators of embryofetal toxicity (reduction in litter size, decreased number of viable fetuses, increased post-implantation loss) were noted at doses ≥0.2 mg/kg/day (0.2X MTHD). Additional fetal effects noted in this study included delayed ossification noted at doses ≥0.1 mg/kg/day and an increased incidence of fetal malformations (primarily skeletal malformations) noted at doses ≥0.2 mg/kg/day.
A dose at which no treatment-related effects on embryofetal toxicity or teratogenicity were observed was not established in this study. Additional systemic embryofetal development studies were conducted in rats and mice. Subcutaneous doses of 0.1 and 9 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 9 to 15.
In the presence of maternal toxicity, an increase in fetal deaths and fetal resorptions and an increase in the number of ossifications in caudal vertebrae were noted at a dose of 9 mg/kg/day (3X MTHD). No treatment-related effects on embryofetal toxicity or teratogenicity were noted at 0.1 mg/kg/day (0.1X MTHD). Subcutaneous doses of 0.2 and 1 mg/kg/day hydrocortisone butyrate were administered to pregnant female mice during gestation days 7 to 13.
In the absence of maternal toxicity, an increased number of cervical ribs and one fetus with clubbed legs were noted at a dose of 1 mg/kg/day (0.2X MTHD). No treatment-related effects on embryofetal toxicity or teratogenicity were noted at doses of 1 and 0.2 mg/kg/day, respectively (0.2X MTHD and 0.1X MTHD, respectively). No topical embryofetal development studies were conducted with hydrocortisone butyrate lotion.
However, topical embryofetal development studies were conducted in rats and rabbits with a hydrocortisone butyrate ointment formulation. Topical doses of 1% and 10% hydrocortisone butyrate ointment were administered to pregnant female rats during gestation days 6 to 15 or pregnant female rabbits during gestation days 6 to 18. A dose- dependent increase in fetal resorptions was noted in rabbits (0.2 to 2X MTHD) and fetal resorptions were noted in rats at the 10% hydrocortisone butyrate ointment dose (80X MTHD).
No treatment-related effects on embyrofetal toxicity were noted at the 1% hydrocortisone buty… [Excerpted — this section continues on DailyMed.]
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Topical corticosteroids share anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical corticosteroids 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 .
12.3Pharmacokinetics No studies were conducted to determine the pharmacokinetics of hydrocortisone butyrate lotion. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed through normal intact skin.
Inflammation and/or other disease processes in the skin, occlusive dressings, or widespread application may increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Hydrocortisone butyrate lotion, 0.1%, is white to off white in color and supplied in bottles of 2 fl. oz. (NDC 68180-951-01) and 4 fl. oz. (NDC 68180-951-02). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.
📋 Description ▾
11 DESCRIPTION Hydrocortisone butyrate lotion, 0.1% contains hydrocortisone butyrate, a non- fluorinated hydrocortisone ester, for topical use. The chemical name of hydrocortisone butyrate is 11 β ,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate. It has the following structural formula: Hydrocortisone butyrate USP is a white crystalline powder with a molecular weight of 432.56, and a molecular formula of C 25 H 36 O 6 .
It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of hydrocortisone butyrate lotion, 0.1% contains 1 mg of hydrocortisone butyrate USP in a white to off white lotion base consisting of butylated hydroxytoluene, butylparaben, ceteth-20, cetostearyl alcohol, citric acid monohydrate, light mineral oil, propylparaben, purified water, sodium citrate, and white petrolatum. Image-01
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Patients using hydrocortisone butyrate lotion should receive the following information and instructions: Apply a thin layer to the affected skin two times daily, and rub in gently. Discontinue hydrocortisone butyrate lotion when control is achieved. Do not use for longer than 4 weeks.
Avoid contact with the eyes. Do not bandage, otherwise cover, or wrap the affected skin area so as to be occlusive unless directed by physician. Do not use hydrocortisone butyrate lotion in the diaper area, as diapers or plastic pants may constitute occlusive dressings.
Do not use hydrocortisone butyrate lotion on the face, underarms, or groin areas unless directed by physician. If no improvement is seen within 2 weeks, contact physician. Do not use other corticosteroid -containing products while using hydrocortisone butyrate lotion without first consulting physician.
Rx only LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 India October 2024 ID#: 277876 Image
🔬 Clinical Studies ▾
14 CLINICAL STUDIES In a multicenter, randomized, vehicle-controlled trial of 284 pediatric subjects 3 months to 18 years of age with mild to moderate atopic dermatitis, hydrocortisone butyrate lotion or vehicle was applied twice daily for up to four weeks. Treatment success was assessed at day 29 (after 28 days of treatment) and was defined as the proportion of patients who achieved both "clear" or "almost clear" and at least a two grade improvement from baseline on a 5-point Physician's Global Assessment (PGA) scale.
Study results are shown in Table 3. TABLE 3. Efficacy results at Day 29 in pediatric subjects Hydrocortisone butyrate lotion ( n = 139 ) Vehicle ( n = 145 ) Number (%) successes 68 (49%) 35 (24%) Another multicenter, randomized, double-blind study compared twice daily treatment with hydrocortisone butyrate lotion (n=151) to vehicle (n=150) for three or four weeks in adult subjects (ages 18 years or older) having atopic dermatitis, including those with mild or moderate severity.
Results favored hydrocortisone butyrate lotion over vehicle.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year dermal rat carcinogenicity study with hydrocortisone butyrate lotion, hydrocortisone butyrate was administered to Sprague-Dawley rats at topical doses of 0.05, 0.15, and 0.3 mg/kg/day in males and 0.1, 0.25, and 0.5 mg/kg/day in females (0.1% lotion). No drug-related tumors were noted in this study up to the highest doses evaluated in this study of 0.3 mg/kg/day in males (0.1X MTHD) and 0.5 mg/kg/day in females (0.2X MTHD). Hydrocortisone butyrate revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames test and L5178Y/TK +/- mouse lymphoma assay) and one in vivo genotoxicity test (mouse micronucleus assay).
No evidence of impairment of fertility or effect on mating performance was observed in a fertility and general reproductive performance study conducted in male and female rats at subcutaneous doses up to and including 1.8 mg/kg/day (0.7X MTHD). Mild effects on maternal animals, such as reduced food consumption and a subsequent reduction in body weight gain, were seen at doses ≥ 0.6 mg/kg/day (0.2X MTHD).
📄 Package Label / Principal Display Panel ▾
Hydrocortisone Butyrate Lotion, 0.1% 4 fl oz (118 mL)- Bottle label NDC 68180-951-02 Rx only Hydrocortisone Butyrate Lotion, 0.1% 4 fl oz (118 mL)- Carton label NDC 68180-951-02 Rx only Image- 02 Image- 03