cream

Manufacturer
Oxygen Development LLC
Effective date
2021-02-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:30

Label at a glance#

Productcream
Active ingredientSALICYLIC ACID
Label structure8 sections

Dosage and administration

Cleanse skin thoroughly with non-medicated cleanser before applying medication. Apply a thin layer to desired area and gently pat until concealer is blended in. For best results, apply under make-up. Apply 1-3 times daily. If excessive dryness occurs, reduce daily applications, or use as directed by your physician.

Label contents#

Full prescribing information#

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse skin thoroughly with non-medicated cleanser before applying medication. Apply a thin layer to desired area and gently pat until concealer is blended in. For best results, apply under make-up. Apply 1-3 times daily. If excessive dryness occurs, reduce daily applications, or use as directed by your physician.

Warning

WARNINGS SECTION

For external use only. Use only on non-complex facial acne. Avoid contact with eyes. If contact occurs, immediately flush with water. Do not use with another acne medication, except on the advice of a doctor. If excessive skin irritation develops or increases discontinue use; if irritation persists, consult a doctor.

Medicinal Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2% w/w

Non-Medicinal Ingredients

INACTIVE INGREDIENT SECTION

Octyldodecyl Neopentanoate, Octyldodecanol, Kaolin, Ozokerite, Dipropylene Glycol, Avena Sativa (Oat) Kernel Oil, Hydrogenated Castor Oil, Cetyl Alcohol, Paraffin, Triethoxycaprylylsilane, Phenoxyethanol, Propylparaben, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben. May Contain: Titanium Dioxide, Iron Oxides.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

Anti-Acne

INDICATIONS & USAGE SECTION

Use the concealer to help combat existing pimples or prevent new ones from developing.

Secondary Packaging (Blister)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-060-01_AW61354-060-01_AW61354-060-01_AW61354-060-01_AW

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-060-012023-01-30C16284748780-1f386c649-cac3-0266-e053-dadaa90a7c1aLIFE BRAND CLEAR ACTION ACNE TREATMENT CONCEALER STICK SALICYLIC ACID ACNE MEDICATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-060-01cream1 in 1 BLISTER PACKSTICK11
61354-060-01cream1.9 mg in 1 TUBESTICK1.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-060CREAM (SALICYLIC ACID) STICK [OXYGEN DEVELOPMENT LLC]1Legacy NDC, 2 package rows20210224_bc017b67-de4e-4f0f-e053-2a95a90aa5b6.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-06061354-060-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
bc017b67-de4d-4f0f-e053-2a95a90aa5b6bc017b67-de4e-4f0f-e053-2a95a90aa5b62021-02-23WarningsExact identifier
spl id: bc017b67-de4d-4f0f-e053-2a95a90aa5b6
spl set id: bc017b67-de4e-4f0f-e053-2a95a90aa5b6

Reported adverse events (FAERS/openFDA)#

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