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FDA Approval

UREA 40%

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
October 21, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Urea(40 g in 100 g)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Gabar Health Sciences Corp.

118401847

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

UREA 40%

Product Details

NDC Product Code
82429-308
Route of Administration
TOPICAL
Effective Date
October 21, 2023
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: F68VH75CJCClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
UreaActive
Code: 8W8T17847WClass: ACTIBQuantity: 40 g in 100 g
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