MedPath

Renova

RENOVA (TRETINOIN CREAM) 0.02%

Approved
Approval ID

21cfe6a3-03b9-42f5-8f7f-111c56fe3c59

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 29, 2012

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

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

Tretinoin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42254-165
Application NumberNDA021108
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 25, 2011
FDA Product Classification

INGREDIENTS (14)

Medium-Chain TriglyceridesInactive
Code: C9H2L21V7U
Classification: IACT
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
PropylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
Steareth-2Inactive
Code: V56DFE46J5
Classification: IACT
Steareth-20Inactive
Code: L0Q8IK9E08
Classification: IACT
Xanthan GumInactive
Code: TTV12P4NEE
Classification: IACT
TretinoinActive
Quantity: 0.2 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
Butylated HydroxytolueneInactive
Code: 1P9D0Z171K
Classification: IACT

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Renova - FDA Drug Approval Details