Acne Therapy

Manufacturer
PSODEX USA INC | BERKO ILAC VE KIMYA SANAYI ANONIM SIRKETI-SULTANBEYLI SUBESI
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:11

Label at a glance#

ProductAcne Therapy Bar
Active ingredientSULFUR
Label structure18 sections

Dosage and administration

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

Storage and handling

Store at controlled room temperature 59-86°F

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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

DOSAGE & ADMINISTRATION SECTION

Active ingredient: Sulfur 3%

Purpose: Acne treatment

OTC - ACTIVE INGREDIENT SECTION

​Active ingredient: Sulfur 3%

Purpose: Acne treatment

OTC - PURPOSE SECTION

Purpose: Acne treatment

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

Use: For the treatment of acne

INFORMATION FOR OWNERS/CAREGIVERS SECTION

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:

INSTRUCTIONS FOR USE SECTION

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:

OTC - ASK DOCTOR SECTION

You are pregnant or breastfeeding.

​Ask a doctor before use if:

OTC - PREGNANCY OR BREAST FEEDING SECTION

You are pregnant or breastfeeding.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

Condition worsens or does not improve after regular use of this product as directed.

Questions or Comments:

OTC - QUESTIONS SECTION

1 844 4PSODEX | info@psodexusa.com

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use :

OTC - DO NOT USE SECTION

On damaged or irritated skin not caused by acne or on the sensitive skin

When using this product :

OTC - WHEN USING SECTION

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 :

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59-86°F

Warnings:

WARNINGS SECTION

For external use only

Acne Therapy Soap Bar

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
248410sulfur 3 % Medicated Bar SoapPSN2
248410sulfur 0.03 MG/MG Medicated Bar SoapSCD2
248410sulfur 3 % Medicated Bar SoapSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73503-013-00Acne TherapyBar1000 g in 1 BOXSOAP10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73503-013ACNE THERAPY BAR (SULFUR) SOAP [PSODEX USA INC]21 package rows20240101_03253625-7be2-7559-e063-6294a90a540a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73503-01373503-013-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d0e8dea-e6de-3e60-e063-6294a90aa7d403253625-7be2-7559-e063-6294a90a540a2023-12-21WarningsExact identifier
spl id: 0d0e8dea-e6de-3e60-e063-6294a90aa7d4
spl set id: 03253625-7be2-7559-e063-6294a90a540a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.