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
NDC Product Code16110-915
Application NumberNDA021184
Marketing CategoryC73594
Route of AdministrationCUTANEOUS
Effective DateFebruary 3, 2020
Generic Nametazarotene
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
NDC Product Code16110-916
Application NumberNDA021184
Marketing CategoryC73594
Route of AdministrationCUTANEOUS
Effective DateFebruary 3, 2020
Generic Nametazarotene
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