HYDROCORTISONE BUTYRATE 1 mg/mL
HYDROCORTISONE BUTYRATE · LOTION · Oceanside Pharmaceuticals
HYDROCORTISONE BUTYRATE is a lotion containing hydrocortisone butyrate at 1 mg/mL, taken topical. Manufactured by Oceanside Pharmaceuticals.
Key Facts
- Brand Name
- HYDROCORTISONE BUTYRATE
- Generic Name
- HYDROCORTISONE BUTYRATE
- NDC Code (Product)
68682-392- Manufacturer
- Oceanside Pharmaceuticals
- Strength
- 1 mg/mL
- Dosage Form
- LOTION
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA022076
- Marketing Start
- 06/08/2018
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Hydrocortisone Butyrate Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Hydrocortisone Butyrate Lotion is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Apply Hydrocortisone Butyrate Lotion for up to 2 weeks as a thin layer to the affected skin two times daily and rub in gently. Discontinue Hydrocortisone Butyrate Lotion when control is achieved. If no improvement is seen within 2 weeks, consider reassessment of the diagnosis. Before prescribing for more than 2 weeks, the additional benefits of extending treatment up to 4 weeks should be weighed against the risk of endocrine system adverse reactions and local adverse reactions [ see Warnings and Precautions (5.1), Adverse Reactions (6.1, 6.2) ]. Hydrocortisone Butyrate Lotion is not for oral, ophthalmic, or intravaginal use. Do not use Hydrocortisone Butyrate Lotion [ see Warnings and Precautions (5.1) ]: o With occlusive dressings unless directed by a healthcare provider. Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings. o On the face, underarms, or groin areas unless directed by a healthcare provider. Apply a thin layer to the affected skin two times daily. ( 2 ) Rub in gently. ( 2 ) Discontinue Hydrocortisone Butyrate Lotion when control is achieved. ( 2 ) Reassess diagnosis if no improvement is seen within …
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • HPA axis suppression [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)] • Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5. 2)] • Skin infections [see Warnings and Precautions (5.3)] • Allergic contact dermatitis [see Warnings and Precautions (5.4)] The most common adverse reactions (> 1%) are application site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact The J. Molner Company LLC at 1-800-552-8750 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION. Revised: 11/2023 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of the drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect Hydrocortisone Butyrate Lotion applied topically twice daily for up to 4 weeks in vehicle-controlled clinical trials of 284 pediatric subjects 3 months to 18 years of age a…
Frequently Asked Questions
What is HYDROCORTISONE BUTYRATE used for?
HYDROCORTISONE BUTYRATE contains HYDROCORTISONE BUTYRATE. It is a lotion taken topical. Consult your doctor for specific uses.
Is HYDROCORTISONE BUTYRATE a controlled substance?
HYDROCORTISONE BUTYRATE is not classified as a controlled substance by the DEA.
What is the generic name for HYDROCORTISONE BUTYRATE?
The generic name for HYDROCORTISONE BUTYRATE is HYDROCORTISONE BUTYRATE. There are 9 other brand versions of HYDROCORTISONE BUTYRATE.
What is the NDC code for HYDROCORTISONE BUTYRATE 1 mg/mL?
The NDC (National Drug Code) for HYDROCORTISONE BUTYRATE 1 mg/mL is 68682-392, listed by Oceanside Pharmaceuticals.
Other Hydrocortisone Brands
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- Hydrocortisone Butyrate1 mg/mL68180-951
- Hydrocortisone Butyrate1 mg/mL83148-012
- Hydrocortisone Butyrate1 mg/g51672-4074
- Hydrocortisone Butyrate1 mg/mL72162-2630
- Evesse1 mg/mL87143-420
- Hydrocortisone Butyrate1 mg/mL51672-4061
- Hydrocortisone Butyrate1 mg/g68682-384
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)