Tretinoin by Zydus Lifesciences Limited TRETINOIN cream

Tretinoin by

Drug Labeling and Warnings

Tretinoin by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1873-2

Tretinoin cream USP, 0.1%

20 grams

Rx

INGREDIENTS AND APPEARANCE

TRETINOIN 
tretinoin cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1873
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)	TRETINOIN	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
SORBIC ACID (UNII: X045WJ989B)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1873-2	1 in 1 CARTON	04/30/2024
1		20 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70771-1873-4	1 in 1 CARTON	04/30/2024
2		45 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA218561	04/30/2024

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		650650802	ANALYSIS(70771-1873) , MANUFACTURE(70771-1873)