FDA.reportPublic FDA data

CLARIFAST One Step Acne Treatment

Manufacturer
VIREO SYSTEMS, INC.
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:13

Label at a glance#

ProductCLARIFAST One Step Acne Treatment
Active ingredientSALICYLIC ACID
Label structure7 sections

Indications and uses

• For the treatment of acne. • Helps clear acne blemishes, pimples, and blackheads. • Penetrates pores to reduce the number of acne blemishes, pimples and blackheads. • Helps prevent new acne blemishes, pimples, and blackheads from forming. • Helps prevent the development of new acne blemishes, pimples and blackheads.

Dosage and administration

• Apply to affected area and rub in lightly, one to two times daily (before bedtime or anytime during the day as desired). Allow 30 minutes to dry • If drying of the skin occurs, reduce application to once a day, every other day, or as directed by a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5 %

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses:

INDICATIONS & USAGE SECTION

• For the treatment of acne. • Helps clear acne blemishes, pimples, and blackheads. • Penetrates pores to reduce the number of acne blemishes, pimples and blackheads. • Helps prevent new acne blemishes, pimples, and blackheads from forming. • Helps prevent the development of new acne blemishes, pimples and blackheads.



Warnings:

WARNINGS SECTION

for external use only.

When using this product: 

OTC - WHEN USING SECTION

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

• Apply to affected area and rub in lightly, one to two times daily (before bedtime or anytime during the day as desired). Allow 30 minutes to dry • If drying of the skin occurs, reduce application to once a day, every other day, or as directed by a doctor.

Other information:

SPL UNCLASSIFIED SECTION

• Protect the product in this container from excessive heat and direct sun. Store at a controlled room temperature 20-25C (68-77F).

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Alpha-GEE®, Aloe Barbadensis Leaf Extract, Amezol®, Bellis Perennis Flower Extract, Cetyl Alcohol, Coconut Oil, Colloidal Oatmeal,  Denatured  Alcohol, Glyceryl Monostearate, Hamamelis Virginiana Extract 3X, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Polyethylene Glycol 400, Polyethylene Glycol 3350, Potassium Phosphate Dibasic, Propylene Glycol, Sulfur 1X, Zinc Oxide.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
248684salicylic acid 0.5 % Topical CreamPSN2
248684salicylic acid 5 MG/ML Topical CreamSCD2
248684salicylic acid 0.5 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82908-358-00CLARIFAST One Step Acne Treatment81.33 mL in 1 JARCREAM81.332

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82908-358CLARIFAST ONE STEP ACNE TREATMENT (SALICYLIC ACID) CREAM [VIREO SYSTEMS, INC.]2Current NDC, Legacy NDC, 1 package rows20231112_b20a0f00-4bf2-4583-b399-7097542fff90.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82908-35882908-358-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
BELLIS PERENNIS FLOWER26I94X9A1KIACT
CETYL ALCOHOL936JST6JCNIACT
COCONUT OILQ9L0O73W7LIACT
OATMEAL8PI54V663YIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
TEA TREE OILVIF565UC2GIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ZINC OXIDESOI2LOH54ZIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
CLARIFAST One Step Acne TreatmentSALICYLIC ACIDVIREO SYSTEMS, INC.b20a0f00-4bf2-4583-b399-7097542fff902023-11-11WarningsExact identifier
ndc (package): 82908-358-00
ndc (product): 82908-358
ndc11 (package): 82908035800
spl id: 09e37389-88df-6f4c-e063-6394a90a9861
spl set id: b20a0f00-4bf2-4583-b399-7097542fff90

Reported adverse events (FAERS/openFDA)#

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