CORTI-SAV- hydrocortisone 1% iodoquinol cream 
Prime Labs LLC DBA Quality CDMO

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Corti-Sav

Contains hydrocortisone 1% and iodoquinol 1%

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.

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.

carton

CORTI-SAV 
hydrocortisone 1% iodoquinol cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80587-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
IODOQUINOL (UNII: 63W7IE88K8) (IODOQUINOL - UNII:63W7IE88K8) IODOQUINOL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
CETEARETH-25 (UNII: 8FA93U5T67)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETEARETH-6 (UNII: 2RJS3559D3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80587-101-0128.4 g in 1 TUBE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/202006/01/2020
Labeler - Prime Labs LLC DBA Quality CDMO (117658386)
Registrant - Prime Labs LLC DBA Quality CDMO (117658386)

Revised: 6/2022
 
Prime Labs LLC DBA Quality CDMO