ROSACEA THERAPY MOISTURIZING- azelaic acid, tranexamic acid cream 
PSODEX USA INC

----------

Rosacea Therapy Moisturizing Cream

Rosacea Therapy Moisturizing Cream

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:

Active ingredient:

Azelaic Acid 5%
Tranexamic Acid 1%

Purpose:

Rosacea Treatment

Rosacea Therapy Moisturizing Cream ​

​Active ingredient:

Azelaic Acid 5%
Tranexamic Acid 1%




Rosacea Therapy Moisturizing Cream

Purpose:
Rosacea Treatment

Rosacea Therapy Moisturizing Cream

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

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

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

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

​Rosacea Therapy Moisturizing Cream

Do not use:

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

​Rosacea Therapy Moisturizing Cream

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

Questions or Comments:

1 844 4PSODEX | info@psodexusa.com

Stop use and ask a doctor if

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

When using this product

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

Other information

Store at controlled room temperature 59-86°F

Warnings

For external use only

Use

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

ROSACEA THERAPY  MOISTURIZING
azelaic acid, tranexamic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73503-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1) TRANEXAMIC ACID1 g  in 100 mL
AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT) AZELAIC ACID5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z) 2 g  in 100 mL
DEHYDROACETIC ACID (UNII: 2KAG279R6R) 0.25 g  in 100 mL
MENTHA PIPERITA LEAF (UNII: A389O33LX6) 5 g  in 100 mL
MINERAL OIL (UNII: T5L8T28FGP) 5 g  in 100 mL
POLIDOCANOL (UNII: 0AWH8BFG9A) 3 g  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.5 g  in 100 mL
OCTYLDODECANOL (UNII: 461N1O614Y) 2 g  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 5 g  in 100 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40) 0.2 g  in 100 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) 1 g  in 100 mL
WATER (UNII: 059QF0KO0R) 43.5 mL  in 100 mL
UREA (UNII: 8W8T17847W) 5 g  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z) 1 g  in 100 mL
LEVOMENOL (UNII: 24WE03BX2T) 2 g  in 100 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 2 g  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE) 0.3 g  in 100 mL
CETYL ALCOHOL (UNII: 936JST6JCN) 5 g  in 100 mL
DI-C12-13 ALKYL MALATE (UNII: RRL7C51WPD) 2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) 9 g  in 100 mL
BENZOIC ACID (UNII: 8SKN0B0MIM) 0.25 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73503-009-011000 in 1 BOX01/01/2024
1NDC:73503-009-001000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00601/01/2024
Labeler - PSODEX USA INC (076051073)
Registrant - PSODEX USA INC (076051073)

Revised: 12/2023
Document Id: 0db01f99-4bf4-ee38-e063-6294a90afba9
Set id: 0324f0b9-3e5c-0c3c-e063-6394a90a93d6
Version: 2
Effective Time: 20231229
 
PSODEX USA INC