TAZORAC
These highlights do not include all the information needed to use TAZORAC Cream safely and effectively. See full prescribing information for TAZORAC Cream. TAZORAC (tazarotene) cream, 0.05% and 0.1%, for topical use Initial U.S. Approval: 1997
Approved
Approval ID
021744d1-a6d7-4ad6-99c2-7187c24e64c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2022
Manufacturers
FDA
Almirall, LLC
DUNS: 605425912
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tazarotene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16110-915
Application NumberNDA021184
Product Classification
M
Marketing Category
C73594
G
Generic Name
tazarotene
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateFebruary 3, 2020
FDA Product Classification
INGREDIENTS (11)
tazaroteneActive
Quantity: 0.05 mg in 1 g
Code: 81BDR9Y8PS
Classification: ACTIB
Benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
carbomer 1342Inactive
Code: 809Y72KV36
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERYL CAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
sodium thiosulfateInactive
Code: HX1032V43M
Classification: IACT
sorbitan monooleateInactive
Code: 06XEA2VD56
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
tazarotene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16110-916
Application NumberNDA021184
Product Classification
M
Marketing Category
C73594
G
Generic Name
tazarotene
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateFebruary 3, 2020
FDA Product Classification
INGREDIENTS (11)
tazaroteneActive
Quantity: 0.1 mg in 1 g
Code: 81BDR9Y8PS
Classification: ACTIB
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
carbomer 1342Inactive
Code: 809Y72KV36
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERYL CAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
sorbitan monooleateInactive
Code: 06XEA2VD56
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
sodium thiosulfateInactive
Code: HX1032V43M
Classification: IACT