Hydrocortisone Butyrate
Hydrocortisone Butyrate Cream, USP, 0.1% For Dermatological Use Only
Approved
Approval ID
0db4485b-2924-4113-af76-117ad48367b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocortisone Butyrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-971
Application NumberNDA018514
Product Classification
M
Marketing Category
C73594
G
Generic Name
Hydrocortisone Butyrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 2009
FDA Product Classification
INGREDIENTS (9)
HYDROCORTISONE BUTYRATEActive
Quantity: 1.0 mg in 1 g
Code: 05RMF7YPWN
Classification: ACTIB
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT