Retin-A MICRO
RETIN-A MICRO® (tretinoin gel) microsphere, 0.1% and 0.04%
Approved
Approval ID
78f03983-f636-43c3-90c5-3d5231909b2a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 4
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 Code54868-5926
Application NumberNDA020475
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (10)
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
TretinoinActive
Quantity: 1 mL in 1 g
Code: 5688UTC01R
Classification: ACTIB
Butylated HydroxytolueneInactive
Code: 1P9D0Z171K
Classification: IACT
Carbomer Homopolymer Type BInactive
Code: HHT01ZNK31
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sorbic AcidInactive
Code: X045WJ989B
Classification: IACT
TrolamineInactive
Code: 9O3K93S3TK
Classification: IACT
Tretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5854
Application NumberNDA020475
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (10)
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
TretinoinActive
Quantity: 400 mL in 1 g
Code: 5688UTC01R
Classification: ACTIB
Butylated HydroxytolueneInactive
Code: 1P9D0Z171K
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)Inactive
Code: K61870Z308
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Sorbic AcidInactive
Code: X045WJ989B
Classification: IACT
TrolamineInactive
Code: 9O3K93S3TK
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Tretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5604
Application NumberNDA020475
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (10)
TretinoinActive
Quantity: 0.4 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
Butylated HydroxytolueneInactive
Code: 1P9D0Z171K
Classification: IACT
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)Inactive
Code: K61870Z308
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sorbic AcidInactive
Code: X045WJ989B
Classification: IACT
TrolamineInactive
Code: 9O3K93S3TK
Classification: IACT
Tretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4497
Application NumberNDA020475
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (10)
TretinoinActive
Quantity: 0.1 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
Butylated HydroxytolueneInactive
Code: 1P9D0Z171K
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Carbomer Homopolymer Type BInactive
Code: HHT01ZNK31
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
TrolamineInactive
Code: 9O3K93S3TK
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Sorbic AcidInactive
Code: X045WJ989B
Classification: IACT