Label: ANTI DANDRUFF INTENSIVE THERAPY- selenium sulfide, zinc pyrithione, salicylic acid shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • DESCRIPTION

    Dandruff is a common condition that causes the skin on the scalp to flake.

    The main goal of treatment is to manage symptoms

    PSODEX Anti Dandruff Shampoo offers a soothing formula that helps block the recurrence of Seborrheic Dermatitis symptoms & Dandruff with the help of SALICYLIC ACID, SELENIUM SULFIDE, and PYRITHIONE ZINC

    PREVENTS:
    Moisture loss and skin irritation


    RELIEVES:
    Itching, inflammation, and roughness


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


    HELPS BLOCK:
    Recurrence of Seborrheic Dermatitis symptoms and Dandruff

  • Active ingredient

    Selenium Sulfide 1%
    Pyrithione Zinc 1%
    Salicylic Acid 1%

  • Active ingredient

    Selenium Sulfide 1%
    Pyrithione Zinc 1%
    Salicylic Acid 1%

  • Inactive Ingredients

    Disodium Cocoamphodiacete, Decyl Glucoside, Distilled
    Water, Mentha Piperita Leaf Extract, Glycerin, Colloidal
    Oatmeal, Phenoxyethanol, Caprylyl Glycol,
    Polyquaternium-10, Guar Hydroxypropyltrimonium
    Chloride, Disodium EDTA, Xanthan Gum, Citric Acid

  • Directions

    Apply shampoo to wet hair and scalp, foam, and massage onto scalp.
    Leave it on for 2-3 minutes.
    Rinse thoroughly.
    For best results, at least use twice a week or as directed by a doctor.

  • Use

    Helps prevent and control the symptoms of dandruff
    and Seborrheic Dermatitis
    Relieves scalp itching, irritation, redness, and flaking
    caused by dandruff and Seborrheic Dermatitis

  • Purpose

    Anti-dandruff,
    Anti-seborrheic

  • Warnings:

    For external use only

  • Other information

    Store at controlled room temperature 59-86°F

  • Ask a doctor before use if:

    Condition covers a
    large area of the body.

  • Keep out of reach of children:

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Do not use

    On large or deep wounds

  • Stop use and ask a doctor if:

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

  • Questions or Comments

    1 844 4PSODEX | info@psodexusa.com

  • When using this product

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

  • 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

  • Anti Dandruff Shampoo Intensive Therapy

    package

  • INGREDIENTS AND APPEARANCE
    ANTI DANDRUFF  INTENSIVE THERAPY
    selenium sulfide, zinc pyrithione, salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73503-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE1 g  in 100 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) 20 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.5 g  in 100 mL
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 10 g  in 100 mL
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK) 0.5 g  in 100 mL
    XANTHAN GUM (UNII: TTV12P4NEE) 0.3 g  in 100 mL
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.5 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 55.9 mL  in 100 mL
    MENTHA PIPERITA LEAF (UNII: A389O33LX6) 5 g  in 100 mL
    OATMEAL (UNII: 8PI54V663Y) 1 g  in 100 mL
    CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.5 g  in 100 mL
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) 0.5 g  in 100 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.3 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73503-012-001000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03201/01/2024
    Labeler - PSODEX USA INC (076051073)
    Registrant - PSODEX USA INC (076051073)
    Establishment
    NameAddressID/FEIBusiness Operations
    BERKO ILAC VE KIMYA SANAYI ANONIM SIRKETI-SULTANBEYLI SUBESI533135007manufacture(73503-012)
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