PEDIADERMICS ECZEMA 2
PEDIADERMICS ECZEMA 2
Approved
Approval ID
da840bf6-ed65-bafc-e053-2a95a90a92d5
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
RENU LABORATORIES, LLC
DUNS: 119451815
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76348-585
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Hydrocortisone
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (21)
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
SORBITOL SOLUTION 70%Inactive
Code: 8KW3E207O2
Classification: IACT
OATInactive
Code: Z6J799EAJK
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
HONEYInactive
Code: Y9H1V576FH
Classification: IACT
PHYTOSPHINGOSINEInactive
Code: GIN46U9Q2Q
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
HYDROCORTISONEActive
Quantity: 1.12 g in 112 g
Code: WI4X0X7BPJ
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
CHOLESTEROLInactive
Code: 97C5T2UQ7J
Classification: IACT
SODIUM LAUROYL LACTYLATEInactive
Code: 7243K85WFO
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CERAMIDE 1Inactive
Code: 5THT33P7X7
Classification: IACT
CERAMIDE NPInactive
Code: 4370DF050B
Classification: IACT
CERAMIDE APInactive
Code: F1X8L2B00J
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 8/15/2022
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 8/15/2022
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 8/15/2022
STATEMENT OF IDENTITY SECTION
LOINC: 69718-5Updated: 8/15/2022
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 8/15/2022
WARNINGS SECTION
LOINC: 34071-1Updated: 8/15/2022
OTC - WHEN USING SECTION
LOINC: 50567-7Updated: 8/15/2022
OTC - STOP USE SECTION
LOINC: 50566-9Updated: 8/15/2022
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 8/15/2022
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 8/15/2022
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 8/15/2022
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 8/15/2022