The following Structured Product Label (SPL) was submitted to the FDA by Psodex Usa Inc for the product Seborrheic Dermatitis (NDC 73503-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding inactive ingredients, description, information for owners/caregivers, active ingredient, use, directions, ask a doctor before use if, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Aloe Barbadensis Leaf Extract, Allantoin, Ascorbic Acid, Benzoic
Acid, a-Bisabolol, Cetyl Alcohol, Chloroxylenol, Dehydroacetic
Acid, Di-C12-13 Alkyl Malate, Dipropylene Glycol, Distilled
Water, Glyceryl Monostearate, Laureth-9, Mentha Piperita
Extract, Octyldodecanol, Panthenol, Paraffinum Liquidum,
Phenoxyethanol, Undecylenic Acid, Urea, Xanthan Gum, Zinc
Oxide
Seborrheic Dermatitis is a chronic inflammatory skin condition that can fluctuate over time.
The main goal of treatment is to manage symptoms
PSODEX Seborrheic Dermatitis Therapy Cream offers a soothing formula that helps block the recurrence of Seborrheic Dermatitis symptoms with the help of SALICYLIC ACID 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
DISTRIBUTED BY: Psodex USA Inc.
9898 Bissonnet St Ste 625 Houston, TX 77036
1-844 4PSODEX www.psodexusa.com
MANUFACTURED FOR
Yesim Derma Laboratories
Pyrithone Zinc 1%
Salicylic Acid 1,5%
Pyrithone Zinc 1%
Salicylic Acid 1,5%
For the treatment of Seborrheic Dermatitis
Provides relief from the symptoms of Seborrheic Dermatitis, including itching, redness, and scaling of the skin.
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
Condition covers a large area of the body
Condition worsens or does not improve after regular use of this product as directed.
If swallowed, get medical help or contact a Poison Control Center right away.
On large or deep wounds
On damaged or irritated skin not caused by Seborrheic Dermatitis
Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Store at controlled room temperature 59-86°F
1 844 4PSODEX | [email protected]
For external use only
Seborrheic Dermatitis Treatment
* Please review the disclaimer below.
