The following Structured Product Label (SPL) was submitted to the FDA by Psodex Usa Inc for the product Acne Therapy (NDC 73503-013). 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 description, active ingredient / purpose, otc - active ingredient, otc - purpose, inactive ingredients, use, information for owners/caregivers, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acne is a common skin condition that can fluctuate over time.
The main goal of treatment is to manage symptoms.
PSODEX Acne Therapy Soap Bar offers a soothing formula that helps block the recurrence of acne symptoms with the help of SULFUR.
PREVENTS:
Excessive sebum secretion
RELIEVES:
Itching, inflammation, and roughness
CONTROLS:
Flaking and scaling
HELPS BLOCK:
Recurrence of acne symptoms
Active ingredient: Sulfur 3%
Purpose: Acne treatment
Active ingredient: Sulfur 3%
Purpose: Acne treatment
Purpose: Acne treatment
Aloe Barbadensis Extract,
Allantoin, Benzalkonium Chloride, Camellia Sinensis Extract,
Citric Acid, Colloidal Oatmeal, Distilled Water, Glycerin,
Mentha Piperita Leaf Extract, Melaleuca Alternifolia Leaf Oil,
Permethrin, Sodium Chloride, Sodium Citrate, Sodium
Laurate, Sodium Stearate, Sorbitol, Tetrasodium Etidronate
Use: For the treatment of 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
Wet affected area with warm water. Foam the soap in hands and apply to the affected area. Massage gently into the skin for 10-20 seconds, then rinse thoroughly. Use up to 2 times per day or as directed by a doctor. Avoid excessive drying of the skin by limiting the
time of contact to 10 seconds or less each time
You are pregnant or breastfeeding.
You are pregnant or breastfeeding.
Condition worsens or does not improve after regular use of this product as directed.
1 844 4PSODEX | [email protected]
If swallowed, get medical help or contact a Poison Control Center right away.
On damaged or irritated skin not caused by acne or on the sensitive skin
Avoid contact with hair and dyed fabrics, which may be bleached by this product.
Skin irritation may occur. Start with one application daily, then gradually increase to two times daily if needed, or as directed by a doctor
Store at controlled room temperature 59-86°F
For external use only
* Please review the disclaimer below.
