Basic Information
Hydrocortisone Butyrate
68462-464
Regulatory Information
68462-464
ANDA202145
C73584
June 29, 2018
USA
These highlights do not include all the information needed to use HYDROCORTISONE BUTYRATE CREAM safely and effectively. See full prescribing information for HYDROCORTISONE BUTYRATE CREAM. HYDROCORTISONE BUTYRATE Cream, 0.1% (Lipophilic) for topical useInitial U.S. Approval: 1982
HUMAN PRESCRIPTION DRUG LABEL
5
Company Information
130597813
Active Ingredients
CETOSTEARYL ALCOHOL
Code: 2DMT128M1S
Class Code: IACT
MINERAL OIL
Code: T5L8T28FGP
Class Code: IACT
GLYCERYL MONOSTEARATE
Code: 230OU9XXE4
Class Code: IACT
PETROLATUM
Code: 4T6H12BN9U
Class Code: IACT
SORBITAN MONOSTEARATE
Code: NVZ4I0H58X
Class Code: IACT
ANHYDROUS CITRIC ACID
Code: XF417D3PSL
Class Code: IACT
WATER
Code: 059QF0KO0R
Class Code: IACT
ANHYDROUS TRISODIUM CITRATE
Code: RS7A450LGA
Class Code: IACT
PROPYLPARABEN
Code: Z8IX2SC1OH
Class Code: IACT
BUTYLPARABEN
Code: 3QPI1U3FV8
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
Active Moieties
HYDROCORTISONE
Code: WI4X0X7BPJ