Bioelements
Immediate Comfort
Approved
Approval ID
4c561849-e91b-4790-b6e7-8222e22df5f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2012
Manufacturers
FDA
Bioelements, Inc.
DUNS: 174813923
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocortisone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49825-126
Application Numberpart348
Product Classification
M
Marketing Category
C73604
G
Generic Name
Hydrocortisone Acetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 27, 2012
FDA Product Classification
INGREDIENTS (14)
HYDROCORTISONE ACETATEActive
Quantity: 0.088 mL in 88 mL
Code: 3X7931PO74
Classification: ACTIB
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT