FDA.reportPublic FDA data

Rosacea Therapy Moisturizing Cream

Manufacturer
PSODEX USA INC
Effective date
2023-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:10

Label at a glance#

ProductRosacea Therapy Moisturizing
Active ingredientTRANEXAMIC ACID, AZELAIC ACID
Label structure17 sections

Storage and handling

Store at controlled room temperature 59-86°F

Label contents#

Full prescribing information#

Rosacea Therapy Moisturizing Cream

DESCRIPTION SECTION

Rosacea is a chronic inflammatory skin condition that can fluctuate over time.

The main goal of treatment is to manage symptoms

PSODEX Rosacea Therapy Moisturizing Cream offers a soothing formula that helps block the recurrence of Rosacea symptoms with the help of AZELAIC ACID and TRANEXAMIC ACID

PREVENTS:
Moisture loss and skin irritation


RELIEVES:
Itching, inflammation, and roughness


CONTROLS:
Flaking, scaling, eruption, and excessive sebum secretion


HELPS BLOCK:
Recurrence of rosacea symptoms

Rosacea Therapy Moisturizing Cream Active ingredient:

DOSAGE & ADMINISTRATION SECTION

Active ingredient:

Azelaic Acid 5%
Tranexamic Acid 1%

Purpose:

Rosacea Treatment

Rosacea Therapy Moisturizing Cream ​

OTC - ACTIVE INGREDIENT SECTION

​Active ingredient:

Azelaic Acid 5%
Tranexamic Acid 1%




Rosacea Therapy Moisturizing Cream

OTC - PURPOSE SECTION

Purpose:
Rosacea Treatment

Rosacea Therapy Moisturizing Cream

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

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

​Rosacea Therapy Moisturizing Cream

INSTRUCTIONS FOR USE SECTION

Directions:

Cleanse the skin thoroughly before applying the product
Apply to affected areas with a thin layer, one to three times
daily or as directed by a doctor

​Rosacea Therapy Moisturizing Cream

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

​Rosacea Therapy Moisturizing Cream

OTC - ASK DOCTOR SECTION

Ask a doctor before use if : Condition covers a large area of the body

​Rosacea Therapy Moisturizing Cream

OTC - DO NOT USE SECTION

Do not use:

On large or deep wounds
On damaged or irritated skin not caused by Rosacea

​Rosacea Therapy Moisturizing Cream

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.

Questions or Comments:

OTC - QUESTIONS SECTION

1 844 4PSODEX | info@psodexusa.com

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition worsens or does not improve after regular use of this product as directed.

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59-86°F

Warnings

WARNINGS SECTION

For external use only

Use

INDICATIONS & USAGE SECTION

Treats and controls symptoms of Rosacea
Reduces redness and inflammation associated with Rosacea
Promotes even skin tone
Minimizes the appearance of blood vessels

Rosacea Therapy Moisturizing Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagePackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2672350azelaic acid 5 % / tranexamic acid 1 % Topical CreamPSN2
2672350azelaic acid 50 MG/ML / tranexamic acid 10 MG/ML Topical CreamSCD2
2672350azelaic acid 5 % / tranexamic acid 1 % Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
AZELAIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
TRANEXAMIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8234c772-5c41-424c-a33e-e06e8c4de9c1Product name220250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923bProduct name420250224
2d2ef081-4f0c-4669-81e8-32b263669a0aProduct name120230801
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
af534dc0-c9e5-19a6-693c-e7ad53714660Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73503-009-00Rosacea TherapyMoisturizing1000 mL in 1 BOTTLE, PUMPCREAM10002
73503-009-01Rosacea TherapyMoisturizing1000 in 1 BOXCREAM10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73503-009ROSACEA THERAPY MOISTURIZING (AZELAIC ACID, TRANEXAMIC ACID) CREAM [PSODEX USA INC]22 package rows20240101_0324f0b9-3e5c-0c3c-e063-6394a90a93d6.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73503-00973503-009-00, 73503-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRANEXAMIC ACID6T84R30KC1ACTIB
AZELAIC ACIDF2VW3D43YTACTIB
ALLANTOIN344S277G0ZIACT
DEHYDROACETIC ACID2KAG279R6RIACT
MENTHA PIPERITA LEAFA389O33LX6IACT
MINERAL OILT5L8T28FGPIACT
POLIDOCANOL0AWH8BFG9AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
OCTYLDODECANOL461N1O614YIACT
ALOE VERA LEAFZY81Z83H0XIACT
DIPROPYLENE GLYCOLE107L85C40IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
WATER059QF0KO0RIACT
UREA8W8T17847WIACT
PANTHENOLWV9CM0O67ZIACT
LEVOMENOL24WE03BX2TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
XANTHAN GUMTTV12P4NEEIACT
CETYL ALCOHOL936JST6JCNIACT
DI-C12-13 ALKYL MALATERRL7C51WPDIACT
ZINC OXIDESOI2LOH54ZIACT
BENZOIC ACID8SKN0B0MIMIACT

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
0db01f99-4bf4-ee38-e063-6294a90afba90324f0b9-3e5c-0c3c-e063-6394a90a93d62023-12-29WarningsExact identifier
spl id: 0db01f99-4bf4-ee38-e063-6294a90afba9
spl set id: 0324f0b9-3e5c-0c3c-e063-6394a90a93d6

Reported adverse events (FAERS/openFDA)#

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