Label: ROSACEA THERAPY MOISTURIZING- azelaic acid, tranexamic acid cream

  • NDC Code(s): 73503-009-00, 73503-009-01
  • Packager: PSODEX USA INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

If you are a consumer or patient please visit this version.

  • 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

  • INGREDIENTS AND APPEARANCE
    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)