Corti-Sav

Manufacturer
Prime Labs LLC DBA Quality CDMO
Effective date
2022-02-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:07:50

Label at a glance#

ProductCorti-Sav
Active ingredientHYDROCORTISONE, IODOQUINOL
Label structure4 sections

Storage and handling

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Keep the container tightly closed. NOTICE Protect from freezing and excessive heat.

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Contains hydrocortisone 1% and iodoquinol 1%

CLINICAL PHARMACOLOGY SECTION

Hydrocortisone has an anti-inflammatory, antipruritic and vasoconstrictive properties. While the mechanism of anti-inflammatory activity is unclear, there is evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and the therapeutic efficacy in humans lodoquinol has both antifungal and antibacterial properties.

Pharmacokinetics

The extent of the percutaneous absorption of topical steroids is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. Hydrocortisone can be absorbed from normal intact skin. Inflammation and/or other inflammatory disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, hydrocortisone is metabolized in the liver and most body tissue to hydrogeneted and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone. There are no data available regarding the percutaneous absorption of iodoquinol; however, following oral administration, 3-5% of the dose was recovered in the urine as glucuronide.

STORAGE AND HANDLING SECTION

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Keep the container tightly closed.

NOTICE

Protect from freezing and excessive heat.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80587-10180587-101-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e221e080-8c3d-d3b9-e053-2a95a90a4603d8e12be1-af10-68f6-e053-2995a90a77822022-06-23Exact identifier
spl set id: d8e12be1-af10-68f6-e053-2995a90a7782

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.