Tazarodex Cream Plaque Psoriasis & Acne

Manufacturer
PSODEX USA INC | BERKO ILAC VE KIMYA SANAYI ANONIM SIRKETI-SULTANBEYLI SUBESI
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:06:10

Label at a glance#

ProductTazarodex Plaque Psoriasis and Acne
Active ingredientTAZAROTENE
Label structure17 sections

Dosage and administration

Directions: Use on affected areas. Make sure the affected area is dry before use. If you are using a moisturizer, use Tazarodex Cream at least 1 hour after applying the moisturizer to the affected area. Avoid sun exposure after applying Tazarodex Cream as it will make your skin more sensitive to UV rays for 6 hours. Spread it evenly and avoid excessive application. For best results, use only nights or as directed ...

Storage and handling

Other information: Store at controlled room temperature 59-86°F

Label contents#

Full prescribing information#

Tazarodex Cream Plaque Psoriasis & Acne

DESCRIPTION SECTION

Psoriasis is a chronic disease that often comes and goes.


Acne is a common skin condition that can fluctuate over time.

The main goal of treatment is to manage symptoms.

PSODEX Tazarodex Cream offers a soothing formula that helps block the recurrence of plaque psoriasis & acne vulgaris symptoms with the effect of SALICYLIC ACID, UREA, and TAZARATONE.

The main goal of treatment is to manage symptoms.

PREVENTS:
Excessive skin cell growth


RELIEVES:
Itching, inflammation, and roughness


CONTROLS:

Flaking, scaling, and excessive sebum secretion


HELPS BLOCK:
Recurrence of psoriasis and acne symptoms

Tazarodex Cream Plaque Psoriasis & Acne

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Allantoin, a-Bisabolol,Benzoic Acid, Cetyl Alcohol, Dehydroacetic Acid, Di-C12-13 Alkyl Malate, Dipropylene Glycol, Distilled Water, Glyceryl Monostearate, Laureth-9, Mentha Piperita Extract, Octyldodecanol, Panthenol, Paraffinum Liquidum, Phenoxyethanol, Salicylic Acid, Urea, Xanthan Gum

Tazarodex Cream Plaque Psoriasis & Acne

INDICATIONS & USAGE SECTION

Use:

Controls symptoms of plaque psoriasis, acne vulgaris

Tazarodex Cream Plaque Psoriasis & Acne

INFORMATION FOR OWNERS/CAREGIVERS SECTION

DISTRIBUTED BY: Psodex USA Inc.

9898 Bissonnet St Ste 625 Houston, TX 77036

1-844 4PSODEX www.psodexusa.com

MANUFACTURED FOR

Yesim Derma Laboratories

Tazarodex Cream Plaque Psoriasis & Acne - Directions

INSTRUCTIONS FOR USE SECTION

Directions:

Use on affected areas. Make sure the affected area is dry before use. If you are using a moisturizer, use Tazarodex Cream at least
1 hour after applying the moisturizer to the affected area. Avoid sun exposure after applying Tazarodex Cream as it will make your
skin more sensitive to UV rays for 6 hours. Spread it evenly and avoid excessive application. For best results, use only nights or as
directed by a doctor.

Tazarodex Cream Plaque Psoriasis & Acne

OTC - ACTIVE INGREDIENT SECTION

Active ingredient:

Tazarotene 0.1%

Tazarodex Cream Plaque Psoriasis & Acne

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

You have a history of skin sensitivity to topical products or have any medical conditions that affect your skin.

Tazarodex Cream Plaque Psoriasis & Acne

OTC - DO NOT USE SECTION

Do not use:

  • On children under 12 years of age, pregnant or breastfeeding women, or individuals with eczema or retinoid hypersensitivity.
  • For prolonged periods of time without consulting a doctor.
  • In or around the rectum, genital area, or on the groin unless advised by a doctor.
  • On damaged or irritated skin not caused by acne or psoriasis

Tazarodex Cream Plaque Psoriasis & Acne

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.

Tazarodex Cream Plaque Psoriasis & Acne

OTC - PURPOSE SECTION

Purpose:

Plaque Psoriasis & Acne

Tazarodex Cream Plaque Psoriasis & Acne

OTC - QUESTIONS SECTION

Questions or Comments: 1 844 4PSODEX | info@psodexusa.com

Tazarodex Cream Plaque Psoriasis & Acne

OTC - STOP USE SECTION

Stop use and ask a doctor if

Excessive skin irritation/allergic reaction occurs, condition worsens or does not improve after regular use of this product as directed.

Tazarodex Cream Plaque Psoriasis & Acne

OTC - WHEN USING SECTION

When using this product:

  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • Use caution in exposing skin to sunlight after applying this product.
  • It may increase your tendency to sunburn up to 6 hours after application.

​Tazarodex Cream Plaque Psoriasis & Acne

STORAGE AND HANDLING SECTION

Other information:

Store at controlled room temperature 59-86°F

​Tazarodex Cream Plaque Psoriasis & Acne

WARNINGS SECTION

Warnings: For external use only

Tazarodex Cream Plaque Psoriasis & Acne

DOSAGE & ADMINISTRATION SECTION

Tazarotene 0.1%

Tazarodex Cream Plaque Psoriasis & Acne

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGEPACKAGE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313200tazarotene 0.1 % Topical CreamPSN3
313200tazarotene 1 MG/ML Topical CreamSCD3
313200tazarotene 0.1 % Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TAZAROTENE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
5993ea1b-833d-fa4b-caad-a0d477537538Product name520250305
c24b0f4e-b27e-8e2b-a129-1b5a6d72c459Product name220231128
2d2ef081-4f0c-4669-81e8-32b263669a0aProduct name120230801
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
18da2240-e326-4d63-90cd-d6bb15f662a0Product name120200604
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
a32b252c-8cd2-cc4a-c64c-4b9d3916df9eProduct name120140508
af534dc0-c9e5-19a6-693c-e7ad53714660Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73503-007-00TazarodexPlaque Psoriasis and Acne1000 mL in 1 BOTTLE, PUMPCREAM10003
73503-007-01TazarodexPlaque Psoriasis and Acne1000 in 1 BOXCREAM10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73503-007TAZARODEX PLAQUE PSORIASIS AND ACNE (TAZAROTENE) CREAM [PSODEX USA INC]32 package rows20240101_02f948ad-4037-7b63-e063-6394a90a737e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73503-00773503-007-00, 73503-007-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d0ed130-0851-4fac-e063-6394a90ac1dc02f948ad-4037-7b63-e063-6394a90a737e2023-12-21WarningsExact identifier
spl id: 0d0ed130-0851-4fac-e063-6394a90ac1dc
spl set id: 02f948ad-4037-7b63-e063-6394a90a737e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.