Anti Dandruff

Manufacturer
PSODEX USA INC | BERKO ILAC VE KIMYA SANAYI ANONIM SIRKETI-SULTANBEYLI SUBESI
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:10

Label at a glance#

ProductAnti Dandruff Intensive Therapy
Active ingredientPYRITHIONE ZINC, SELENIUM SULFIDE, SALICYLIC ACID
Label structure17 sections

Dosage and administration

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.

Storage and handling

Store at controlled room temperature 59-86°F

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

INSTRUCTIONS FOR USE SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - PURPOSE SECTION

Anti-dandruff,
Anti-seborrheic

Warnings:

WARNINGS SECTION

For external use only

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59-86°F

Ask a doctor before use if:

OTC - ASK DOCTOR SECTION

Condition covers a
large area of the body.

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Do not use

OTC - DO NOT USE SECTION

On large or deep wounds

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

Questions or Comments

OTC - QUESTIONS SECTION

1 844 4PSODEX | info@psodexusa.com

When using this product

OTC - WHEN USING SECTION

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

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

Anti Dandruff Shampoo Intensive Therapy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2672361salicylic acid 1 % / selenium sulfide 1 % / zinc pyrithione 1 % Medicated ShampooPSN2
2672361salicylic acid 10 MG/ML / selenium sulfide 10 MG/ML / zinc pyrithione 10 MG/ML Medicated ShampooSCD2
2672361salicylic acid 1 % / selenium sulfide 1 % / zinc pyrithione 1 % Medicated ShampooSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73503-012-00Anti DandruffIntensive Therapy1000 mL in 1 BOTTLESHAMPOO10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73503-012ANTI DANDRUFF INTENSIVE THERAPY (SELENIUM SULFIDE, ZINC PYRITHIONE, SALICYLIC ACID) SHAMPOO [PSODEX USA INC]21 package rows20240101_03162bab-60ce-f5ca-e063-6294a90a6870.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73503-01273503-012-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
0d0e86c3-de25-3e1f-e063-6394a90a5b1303162bab-60ce-f5ca-e063-6294a90a68702023-12-21WarningsExact identifier
spl id: 0d0e86c3-de25-3e1f-e063-6394a90a5b13
spl set id: 03162bab-60ce-f5ca-e063-6294a90a6870

Reported adverse events (FAERS/openFDA)#

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