MedPath

SkyaDerm-LP

SkyaDerm-LP Kit

Approved
Approval ID

b46a95f3-2633-523c-e053-2995a90a34a2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 17, 2021

Manufacturers
FDA

Skya Health, LLC

DUNS: 117039304

Products 1

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

Lidocaine and Prilocaine Cream

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73086-907
Product Classification
G
Generic Name
Lidocaine and Prilocaine Cream
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 17, 2021
FDA Product Classification

INGREDIENTS (6)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
PEG-60 HYDROGENATED CASTOR OILInactive
Code: 02NG325BQG
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LIDOCAINEActive
Quantity: 25 mg in 1 g
Code: 98PI200987
Classification: ACTIB
PRILOCAINEActive
Quantity: 25 mg in 1 g
Code: 046O35D44R
Classification: ACTIB

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SkyaDerm-LP - FDA Drug Approval Details