TAZARODEX PLAQUE PSORIASIS AND ACNE- tazarotene cream

Tazarodex by

Drug Labeling and Warnings

Tazarodex 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]

Tazarodex Cream Plaque Psoriasis & Acne

Psoriasis is a chronic disease that often comes and goes.

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

The main goal of treatment is to manage symptoms.

PSODEX Tazarodex Cream offers a soothing formula that helps block the recurrence of plaque psoriasis & acne vulgaris symptoms with the effect of SALICYLIC ACID, UREA, and TAZARATONE.

The main goal of treatment is to manage symptoms.

PREVENTS:
Excessive skin cell growth

RELIEVES:
Itching, inflammation, and roughness

CONTROLS:

Flaking, scaling, and excessive sebum secretion

HELPS BLOCK:
Recurrence of psoriasis and acne symptoms

Tazarodex Cream Plaque Psoriasis & Acne

Inactive Ingredients:

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

Tazarodex Cream Plaque Psoriasis & Acne

Use:

Controls symptoms of plaque psoriasis, acne vulgaris

Tazarodex Cream Plaque Psoriasis & Acne

DISTRIBUTED BY: Psodex USA Inc.

9898 Bissonnet St Ste 625 Houston, TX 77036

1-844 4PSODEX www.psodexusa.com

MANUFACTURED FOR

Yesim Derma Laboratories

Tazarodex Cream Plaque Psoriasis & Acne - Directions

Directions:

Use on affected areas. Make sure the affected area is dry before use. If you are using a moisturizer, use Tazarodex Cream at least
1 hour after applying the moisturizer to the affected area. Avoid sun exposure after applying Tazarodex Cream as it will make your
skin more sensitive to UV rays for 6 hours. Spread it evenly and avoid excessive application. For best results, use only nights or as
directed by a doctor.

Tazarodex Cream Plaque Psoriasis & Acne

Active ingredient:

Tazarotene 0.1%

Tazarodex Cream Plaque Psoriasis & Acne

Ask a doctor before use if

You have a history of skin sensitivity to topical products or have any medical conditions that affect your skin.

Tazarodex Cream Plaque Psoriasis & Acne

Do not use:

• On children under 12 years of age, pregnant or breastfeeding women, or individuals with eczema or retinoid hypersensitivity.
• For prolonged periods of time without consulting a doctor.
• In or around the rectum, genital area, or on the groin unless advised by a doctor.
• On damaged or irritated skin not caused by acne or psoriasis

Tazarodex Cream Plaque Psoriasis & Acne

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.

Tazarodex Cream Plaque Psoriasis & Acne

Purpose:

Plaque Psoriasis & Acne

Tazarodex Cream Plaque Psoriasis & Acne

Questions or Comments: 1 844 4PSODEX | info@psodexusa.com

Tazarodex Cream Plaque Psoriasis & Acne

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.

Tazarodex Cream Plaque Psoriasis & Acne

When using this product:

• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
• Use caution in exposing skin to sunlight after applying this product.
• It may increase your tendency to sunburn up to 6 hours after application.

​Tazarodex Cream Plaque Psoriasis & Acne

Other information:

Store at controlled room temperature 59-86°F

​Tazarodex Cream Plaque Psoriasis & Acne

Warnings: For external use only

Tazarodex Cream Plaque Psoriasis & Acne

Tazarotene 0.1%

Tazarodex Cream Plaque Psoriasis & Acne

INGREDIENTS AND APPEARANCE

TAZARODEX  PLAQUE PSORIASIS AND ACNE
tazarotene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73503-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TAZAROTENE (UNII: 81BDR9Y8PS) (TAZAROTENE - UNII:81BDR9Y8PS)	TAZAROTENE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ)	1 g  in 100 mL
DEHYDROACETIC ACID (UNII: 2KAG279R6R)	0.25 g  in 100 mL
DI-C12-13 ALKYL MALATE (UNII: RRL7C51WPD)	2 g  in 100 mL
MINERAL OIL (UNII: T5L8T28FGP)	5 g  in 100 mL
CETYL ALCOHOL (UNII: 936JST6JCN)	5 g  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE)	0.3 g  in 100 mL
ALLANTOIN (UNII: 344S277G0Z)	2 g  in 100 mL
POLIDOCANOL (UNII: 0AWH8BFG9A)	3 g  in 100 mL
MENTHA PIPERITA LEAF (UNII: A389O33LX6)	5 g  in 100 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40)	0.2 g  in 100 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	2 g  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z)	1 g  in 100 mL
BENZOIC ACID (UNII: 8SKN0B0MIM)	0.25 g  in 100 mL
OCTYLDODECANOL (UNII: 461N1O614Y)	2 g  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.5 g  in 100 mL
UREA (UNII: 8W8T17847W)	5 g  in 100 mL
LEVOMENOL (UNII: 24WE03BX2T)	2 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73503-007-01	1000 in 1 BOX	01/01/2024
1	NDC: 73503-007-00	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

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(73503-007)