FDA.reportPublic FDA data

Medicated Gel Cleanser -2% Salicylic Acid

Manufacturer
Only Yourx, Inc.
Effective date
2020-01-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:03:25

Label at a glance#

ProductMedicated Gel Cleanser -2% Salicylic Acid
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Salicylic Acid (2%)

INACTIVE INGREDIENT SECTION

Other Ingredients: Cocamidopropyl Hydrosultaine (Scherctaine SCAB), Disodium EDTA, D-Panthenol, Deionized Water, Disodium Laureth Sulfosuccinate, Ethylhexylglycerin, Eucalyptus Oil, Sage Extract, Witch Hazel, Willow Bark, Glycerin, Isoceteth-20, Phenoxyethanol, Pinus Sylvestre, Potassium Sorbate, Sodium Lauryl Sulfoacetate, Water, Xanthan Gum

DOSAGE & ADMINISTRATION SECTION

Recommended Use: Use daily both morning and night. Cleanse facial and neck area by massaging a liberal amount onto damp skin using upward circular motions. Rinse thoroughly with warm water.

INDICATIONS & USAGE SECTION

To cleanse skin and prevent acne

WARNINGS SECTION

WARNING: For External Use Only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center.

OTC - WHEN USING SECTION

When using this product: using other acne medications at the same time may cause excessive dryness or irritation. Do not use in or near eyes, lips and mouth.

OTC - PURPOSE SECTION

Purpose: acne medication

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medicated Gel CleanserMedicated Gel Cleanser

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN3
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD3
562600salicylic acid 2 % Facial Cleanser TonerSY3
562600salicylic acid 2 % Facial ScrubSY3
562600salicylic acid 2 % Medicated Liquid SoapSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70367-008-452022-07-29C16284748780-1e4f33bdf-a81d-d8a0-e053-dadaa90a6e4e76cde116-0b13-ffe6-e053-2991aa0a9675
70367-008-772022-07-29C16284748780-1e4f33bdf-a81d-d8a0-e053-dadaa90a6e4e76cde116-0b13-ffe6-e053-2991aa0a9675

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70367-008-45Medicated Gel Cleanser -2% Salicylic Acid45 mL in 1 TUBESOAP453
70367-008-77Medicated Gel Cleanser -2% Salicylic Acid228 mL in 1 TUBESOAP2283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70367-008MEDICATED GEL CLEANSER -2% SALICYLIC ACID (SALICYLIC ACID) SOAP [ONLY YOURX, INC.]3Legacy NDC, 2 package rows20200124_76cde116-0b13-ffe6-e053-2991aa0a9675.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
70367-00870367-008-45, 70367-008-77

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DEXPANTHENOL1O6C93RI7ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EUCALYPTUS OIL2R04ONI662IACT
XANTHAN GUMTTV12P4NEEIACT
MAGNESIUM DISODIUM EDTANDT563S5VZIACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
SAGE OILU27K0H1H2OIACT
SODIUM LAURYL SULFOACETATED0Y70F2B9JIACT
SALICYLIC ACIDO414PZ4LPZACTIB
WITCH HAZEL101I4J0U34IACT
WILLOW BARKS883J9JDYXIACT
GLYCERINPDC6A3C0OXIACT
ISOCETETH-20O020065R7ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT

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
9cd5703c-a844-955b-e053-2995a90a87af76cde116-0b13-ffe6-e053-2991aa0a96752020-01-23WarningsExact identifier
spl id: 9cd5703c-a844-955b-e053-2995a90a87af
spl set id: 76cde116-0b13-ffe6-e053-2991aa0a9675

Reported adverse events (FAERS/openFDA)#

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