Label: ACNE THERAPY MOISTURIZING- salicylic acid cream

  • NDC Code(s): 73503-008-00, 73503-008-01
  • Packager: PSODEX USA INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • DESCRIPTION

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

    The main goal of treatment is to manage symptoms

    PSODEX Anti Acne Care Cream offers a soothing formula that helps block the recurrence of acne symptoms with the help of SALICYLIC ACID

    PREVENTS:
    Excessive sebum secretion

    RELIEVES:
    Itching, inflammation, and roughness

    CONTROLS:
    Flaking and scaling

    HELPS BLOCK:
    Recurrence of acne symptoms

  • Active ingredient

    Salicylic Acid 1.5%

  • Active ingredient

    Salicylic Acid 1.5%

  • Inactive Ingredients

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

  • 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
  • Use

    For the treatment of acne
    Helps prevent new acne pimples from forming

  • INFORMATION FOR OWNERS/CAREGIVERS

    DISTRIBUTED BY: Psodex USA Inc.

    9898 Bissonnet St Ste 625 Houston, TX 77036

    1-844 4PSODEX www.psodexusa.com

    MANUFACTURED FOR

    Yesim Derma Laboratories

  • Do not use

    • For prolonged periods of time without consulting a doctor
    • On large or deep wounds
    • On damaged or irritated skin not caused by acne
    • On healthy skin
    • In or around the rectum, genital area, or on the groin unless advised by a doctor
  • Ask a doctor before use if

    Condition covers a large area of the body

  • 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.

  • 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

  • Other information

    Store at controlled room temperature 59-86°F

  • Warnings

    For external use only

  • Purpose

    Acne treatment

  • When using this product

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

  • PRINCIPAL DISPLAY PANEL

    package

  • INGREDIENTS AND APPEARANCE
    ACNE THERAPY  MOISTURIZING
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73503-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LEVOMENOL (UNII: 24WE03BX2T) 2 g  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.5 g  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 5 g  in 100 mL
    POLIDOCANOL (UNII: 0AWH8BFG9A) 3 g  in 100 mL
    OCTYLDODECANOL (UNII: 461N1O614Y) 2 g  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 1 g  in 100 mL
    UREA (UNII: 8W8T17847W) 5 g  in 100 mL
    MENTHA PIPERITA LEAF (UNII: A389O33LX6) 5 g  in 100 mL
    PANTHENOL (UNII: WV9CM0O67Z) 1 g  in 100 mL
    MINERAL OIL (UNII: T5L8T28FGP) 5 g  in 100 mL
    DEHYDROACETIC ACID (UNII: 2KAG279R6R) 0.25 g  in 100 mL
    CHLOROXYLENOL (UNII: 0F32U78V2Q) 0.5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) 5 g  in 100 mL
    XANTHAN GUM (UNII: TTV12P4NEE) 0.3 g  in 100 mL
    ALLANTOIN (UNII: 344S277G0Z) 2 g  in 100 mL
    CETYL ALCOHOL (UNII: 936JST6JCN) 5 g  in 100 mL
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 2 g  in 100 mL
    DIPROPYLENE GLYCOL (UNII: E107L85C40) 0.2 g  in 100 mL
    BENZOIC ACID (UNII: 8SKN0B0MIM) 0.25 g  in 100 mL
    DI-C12-13 ALKYL MALATE (UNII: RRL7C51WPD) 2 g  in 100 mL
    AZELAIC ACID (UNII: F2VW3D43YT) 3 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 43.5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73503-008-011000 in 1 BOX01/01/2024
    1NDC:73503-008-001000 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    BERKO ILAC VE KIMYA SANAYI ANONIM SIRKETI-SULTANBEYLI SUBESI533135007manufacture(73503-008)
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