Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone Butyrate Ointment, 0.1% is supplied in tubes containing: 5 g NDC 51672-4083-5 (as physician samples) 10 g NDC 51672-4083-7 15 g NDC 51672-4083-1 30 g NDC 51672-4083-2 45 g NDC 51672-4083-6 Hydrocortisone Butyrate Cream USP, 0.1% is supplied in tubes containing: 5 g NDC 51672-4074-5 (as physician samples) 10 g NDC 51672-4074-7 15 g NDC 51672-4074-1 30 g NDC 51672-4074-2 45 g NDC 51672-4074-6 Hydrocortisone Butyrate Topical Solution, 0.1% is supplied in polyethylene bottles containing: 20 mL NDC 51672-4061-2 60 mL NDC 51672-4061-4 STORAGE Hydrocortisone Butyrate Ointment, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Hydrocortisone Butyrate Cream USP, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Hydrocortisone Butyrate Topical Solution, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton 20 mL NDC 51672-4061-2 Hydrocortisone Butyrate Topical Solution 0.1% NOT FOR OPHTHALMIC USE. FOR TOPICAL USE ONLY. Rx only TARO PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton; PRINCIPAL DISPLAY PANEL - 15 g Tube Carton - Cream NDC 51672-4074-1 15 g Hydrocortisone Butyrate Cream USP, 0.1% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 15 g Tube Carton - Cream; PRINCIPAL DISPLAY PANEL - 15 g Tube Carton - Ointment NDC 51672-4083-1 15 g Hydrocortisone Butyrate Ointment 0.1% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 15 g Tube Carton - Ointment
- HOW SUPPLIED Hydrocortisone Butyrate Ointment, 0.1% is supplied in tubes containing: 5 g NDC 51672-4083-5 (as physician samples) 10 g NDC 51672-4083-7 15 g NDC 51672-4083-1 30 g NDC 51672-4083-2 45 g NDC 51672-4083-6 Hydrocortisone Butyrate Cream USP, 0.1% is supplied in tubes containing: 5 g NDC 51672-4074-5 (as physician samples) 10 g NDC 51672-4074-7 15 g NDC 51672-4074-1 30 g NDC 51672-4074-2 45 g NDC 51672-4074-6 Hydrocortisone Butyrate Topical Solution, 0.1% is supplied in polyethylene bottles containing: 20 mL NDC 51672-4061-2 60 mL NDC 51672-4061-4 STORAGE Hydrocortisone Butyrate Ointment, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Hydrocortisone Butyrate Cream USP, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Hydrocortisone Butyrate Topical Solution, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
- PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton 20 mL NDC 51672-4061-2 Hydrocortisone Butyrate Topical Solution 0.1% NOT FOR OPHTHALMIC USE. FOR TOPICAL USE ONLY. Rx only TARO PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton
- PRINCIPAL DISPLAY PANEL - 15 g Tube Carton - Cream NDC 51672-4074-1 15 g Hydrocortisone Butyrate Cream USP, 0.1% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 15 g Tube Carton - Cream
- PRINCIPAL DISPLAY PANEL - 15 g Tube Carton - Ointment NDC 51672-4083-1 15 g Hydrocortisone Butyrate Ointment 0.1% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 15 g Tube Carton - Ointment
Overview
Hydrocortisone Butyrate Ointment, Cream and Topical Solution contain the topical corticosteroid, hydrocortisone butyrate, a non-fluorinated hydrocortisone ester. It has the chemical name: 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate; the molecular formula: C 25 H 36 O 6 ; the molecular weight: 432.54; and the CAS registry number: 13609-67-1. Its structural formula is: Chemical Structure Hydrocortisone Butyrate Ointment, 0.1% Each gram of hydrocortisone butyrate ointment contains 1 mg of hydrocortisone butyrate in a base consisting of mineral oil and polyethylene. Hydrocortisone Butyrate Cream USP, 0.1% Each gram of hydrocortisone butyrate cream contains 1 mg of hydrocortisone butyrate in a hydrophilic base consisting of anhydrous citric acid, cetomacrogol 1000, cetostearyl alcohol, light mineral oil, propylparaben and butylparaben (preservatives), purified water, sodium citrate anhydrous and white petrolatum. Hydrocortisone Butyrate Topical Solution, 0.1% Each mL of hydrocortisone butyrate topical solution contains 1 mg of hydrocortisone butyrate in a vehicle consisting of citric acid monohydrate, glycerin, isopropyl alcohol (50% v/v), povidone, purified water and sodium citrate.
Indications & Usage
Hydrocortisone Butyrate Ointment, 0.1% and Hydrocortisone Butyrate Cream USP, 0.1% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Hydrocortisone Butyrate Topical Solution, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of seborrheic dermatitis.
Dosage & Administration
Hydrocortisone Butyrate Ointment, 0.1% or Hydrocortisone Butyrate Cream USP, 0.1% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted. Hydrocortisone Butyrate Topical Solution, 0.1% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.
Warnings & Precautions
No warnings available yet.
Contraindications
None.
Adverse Reactions
The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Storage & Handling
STORAGE Hydrocortisone Butyrate Ointment, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Hydrocortisone Butyrate Cream USP, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Hydrocortisone Butyrate Topical Solution, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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