Arazlo (Page 5 of 5)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 45 gram Carton

NDC 0187-2098-45

For Topical Use Only
Not For Eye Use
Rx only

ARAZLO ® (tazarotene) Lotion, 0.045%

Net Wt. 45 g

Ortho Dermatologics

carton
(click image for full-size original)
ARAZLO tazarotene lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-2098
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAZAROTENE (TAZAROTENE) TAZAROTENE 0.45 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
DIETHYL SEBACATE
EDETATE DISODIUM
LIGHT MINERAL OIL
METHYLPARABEN
PROPYLPARABEN
WATER
SODIUM HYDROXIDE
SORBITAN MONOOLEATE
SORBITOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-2098-45 1 TUBE in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (0187-2098-45)
2 NDC:0187-2098-10 10 TUBE in 1 CARTON contains a TUBE (0187-2098-03)
2 NDC:0187-2098-03 3 g in 1 TUBE This package is contained within the CARTON (0187-2098-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211882 12/19/2019
Labeler — Bausch Health US, LLC (831922468)
Establishment
Name Address ID/FEI Operations
Bausch Health Companies Inc. 245141858 MANUFACTURE (0187-2098)

Revised: 05/2021 Bausch Health US, LLC

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