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

Anti Dandruff by

Drug Labeling and Warnings

Anti Dandruff by is a Otc medication manufactured, distributed, or labeled by PSODEX USA INC, BERKO ILAC VE KIMYA SANAYI ANONIM SIRKETI-SULTANBEYLI SUBESI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73503-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	1 g  in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73503-012-00	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	01/01/2024

Labeler - PSODEX USA INC (076051073)

Registrant - PSODEX USA INC (076051073)

Establishment
Name	Address	ID/FEI	Business Operations
BERKO ILAC VE KIMYA SANAYI ANONIM SIRKETI-SULTANBEYLI SUBESI		533135007	manufacture(73503-012)