MedPath
FDA Product

Tretinoin

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Tretinoin

0378-8093

Regulatory Information

0378-8093

NDA020475

C73605

January 15, 2018

USA

These highlights do not include all the information needed to use Tretinoin Gel safely and effectively. See full prescribing information for Tretinoin Gel . Tretinoin Gel , 0.1% and 0.04% for topical useInitial U.S. Approval: 1997

HUMAN PRESCRIPTION DRUG LABEL

8

Company Information

059295980

Active Ingredients

BUTYLATED HYDROXYTOLUENE

Code: 1P9D0Z171K

Class Code: IACT

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

TRETINOIN

Quantity: 1 mg in 1 g

Code: 5688UTC01R

Class Code: ACTIB

PEG/PPG-18/18 DIMETHICONE

Code: 9H0AO7T794

Class Code: IACT

CYCLOMETHICONE

Code: NMQ347994Z

Class Code: IACT

CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)

Code: HHT01ZNK31

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

PPG-20 METHYL GLUCOSE ETHER DISTEARATE

Code: 0057334FAB

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SORBIC ACID

Code: X045WJ989B

Class Code: IACT

TROLAMINE

Code: 9O3K93S3TK

Class Code: IACT

Active Moieties

TRETINOIN

Code: 5688UTC01R

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