Acne Therapy Moisturizing Cream

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 Moisturizing
Active ingredientSALICYLIC ACID
Label structure17 sections

Dosage and administration

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

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 Anti Acne Care Cream offers a soothing formula that helps block the recurrence of acne symptoms with the help of SALICYLIC ACID

PREVENTS:
Excessive sebum secretion

RELIEVES:
Itching, inflammation, and roughness

CONTROLS:
Flaking and scaling

HELPS BLOCK:
Recurrence of acne symptoms

Active ingredient

DOSAGE & ADMINISTRATION SECTION

Salicylic Acid 1.5%

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1.5%

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Directions

INSTRUCTIONS FOR USE SECTION

  • 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

Use

INDICATIONS & USAGE SECTION

For the treatment of acne
Helps prevent new acne pimples from forming

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

Do not use

OTC - DO NOT USE SECTION

  • For prolonged periods of time without consulting a doctor
  • On large or deep wounds
  • On damaged or irritated skin not caused by acne
  • On healthy skin
  • In or around the rectum, genital area, or on the groin unless advised by a doctor

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

Condition covers a large area of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

Excessive skin irritation/allergic reaction occurs, condition worsens or does not improve after regular use of this product as directed.

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.

Questions or Comments

OTC - QUESTIONS SECTION

1 844 4PSODEX | info@psodexusa.com

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59-86°F

Warnings

WARNINGS SECTION

For external use only

Purpose

OTC - PURPOSE SECTION

Acne treatment

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
248609salicylic acid 1.5 % Topical CreamPSN2
248609salicylic acid 15 MG/ML Topical CreamSCD2
248609salicylic acid 1.5 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d2ef081-4f0c-4669-81e8-32b263669a0aProduct name120230801
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
af534dc0-c9e5-19a6-693c-e7ad53714660Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73503-008-00Acne TherapyMoisturizing1000 mL in 1 BOTTLE, PUMPCREAM10002
73503-008-01Acne TherapyMoisturizing1000 in 1 BOXCREAM10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73503-008ACNE THERAPY MOISTURIZING (SALICYLIC ACID) CREAM [PSODEX USA INC]22 package rows20240101_0324f485-465f-8b7b-e063-6394a90a9b2c.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73503-00873503-008-00, 73503-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
0d0ec3bf-47e4-3390-e063-6394a90a38b80324f485-465f-8b7b-e063-6394a90a9b2c2023-12-21WarningsExact identifier
spl id: 0d0ec3bf-47e4-3390-e063-6394a90a38b8
spl set id: 0324f485-465f-8b7b-e063-6394a90a9b2c

Reported adverse events (FAERS/openFDA)#

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