HYDROCORTISONE 2.5% / KETOCONAZOLE 2% cream

HYDROCORTISONE 2.5% / KETOCONAZOLE 2% by

Drug Labeling and Warnings

HYDROCORTISONE 2.5% / KETOCONAZOLE 2% by is a Prescription medication manufactured, distributed, or labeled by Sincerus Florida, LLC, Sincerus FLorida, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directions for use

Sincerus Florida, LLC. Adverse reactions

Active, inactive

NDC 72934- 2112-2 HYDROCORTISONE USP 2.5% / KETOCONAZOLE USP 2% . Cream 30gm.

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 2.5% / KETOCONAZOLE 2% 
hydrocortisone 2.5% / ketoconazole 2% cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72934-2112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	2.5 g  in 100 g
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	2 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72934-2112-2	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/17/2019

Labeler - Sincerus Florida, LLC (080105003)

Establishment
Name	Address	ID/FEI	Business Operations
Sincerus FLorida, LLC		080105003	manufacture(72934-2112)