VANIQA
Rx only VANIQA(eflornithine hydrochloride) Cream, 13.9% For topical dermatological use only. Not for ophthalmic, oral or intravaginal use.
Approved
Approval ID
a2c3d206-b893-4f65-a2f6-c11fa9a0e486
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
eflornithine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5124
Application NumberNDA021145
Product Classification
M
Marketing Category
C73594
G
Generic Name
eflornithine hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 18, 2012
FDA Product Classification
INGREDIENTS (12)
Polyoxyl 20 Cetostearyl EtherInactive
Code: YRC528SWUY
Classification: IACT
Cetostearyl AlcoholInactive
Code: 2DMT128M1S
Classification: IACT
DimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
Mineral OilInactive
Code: T5L8T28FGP
Classification: IACT
Peg-100 StearateInactive
Code: YD01N1999R
Classification: IACT
PropylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
PhenoxyethanolInactive
Code: HIE492ZZ3T
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Eflornithine HydrochlorideActive
Quantity: 139 mg in 1 g
Code: 4NH22NDW9H
Classification: ACTIR