FDA Label for Acne Therapy Bar
View Indications, Usage & Precautions
- DESCRIPTION
- ACTIVE INGREDIENT / PURPOSE
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INACTIVE INGREDIENTS
- USE
- INFORMATION FOR OWNERS/CAREGIVERS
- DIRECTIONS:
- ASK A DOCTOR BEFORE USE IF:
- ASK A DOCTOR BEFORE USE IF:
- STOP USE AND ASK A DOCTOR IF:
- QUESTIONS OR COMMENTS:
- KEEP OUT OF REACH OF CHILDREN:
- DO NOT USE :
- WHEN USING THIS PRODUCT :
- OTHER INFORMATION :
- WARNINGS:
- ACNE THERAPY SOAP BAR
Acne Therapy Bar Product Label
The following document was submitted to the FDA by the labeler of this product Psodex Usa Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
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 / Purpose
Active ingredient: Sulfur 3%
Purpose: Acne treatment
Otc - Active Ingredient
Active ingredient: Sulfur 3%
Purpose: Acne treatment
Otc - Purpose
Purpose: Acne treatment
Inactive Ingredients
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
Use: For the treatment of acne
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
Directions:
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
Ask A Doctor Before Use If:
You are pregnant or breastfeeding.
Ask A Doctor Before Use If:
You are pregnant or breastfeeding.
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 | [email protected]
Keep Out Of Reach Of Children:
If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use :
On damaged or irritated skin not caused by acne or on the sensitive skin
When Using This Product :
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
Other Information :
Store at controlled room temperature 59-86°F
Warnings:
For external use only
* Please review the disclaimer below.