FDA.reportPublic FDA data

Paulas Choice Clear Anti Redness Exfoliating Solution

Manufacturer
Paula's Choice, LLC
Effective date
2022-01-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:18:51

Label at a glance#

ProductPaulas Choice Clear Anti Redness Exfoliating Solution
Active ingredientSALICYLIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

OTC - PURPOSE SECTION

Acne Treatment

INDICATIONS & USAGE SECTION

Uses

  • Treats acne.
  • Helps clear acne blemishes, blackheads, and whiteheads.
  • Helps prevent new acne blemishes.

DOSAGE & ADMINISTRATION SECTION

Uses

Treats acne.
Helps clear acne blemishes, blackheads, and whiteheads.
Helps prevent new acne blemishes.

WARNINGS SECTION

Warnings

For external use only. Do not use

  • On broken skin
  • On large areas of the body

OTC - WHEN USING SECTION

When using this product

  • Do not use in or near the eyes
  • Using other topical acne products at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor.

OTC - STOP USE SECTION

Stop use and ask a doctor if too much skin irritation or skin sensitivity develops or increases.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help and contact a Poison Control Center immediately.

INSTRUCTIONS FOR USE SECTION

After cleansing with Paula's Choice Clear Pore Normalizing Cleanser, soak a large cotton ball with Extra Strength Anti-Redness Exfoliating Solution and gently stroke over the face, paying special attention to acne and blackhead prone areas. Do not rinse. Avoid contact with eyes, eyelids, and mucous membranes. If contact occurs, rinse with water. If excessive dryness or peeling occurs, reduce application to once per day or once every other day.

INACTIVE INGREDIENT SECTION

  • Water
  • Methylpropanediol
  • Butylene Glycol
  • Camellia Oleifera Leaf Extract
  • Polysorbate 20
  • Tetrasodium EDTA
  • Sodium Hydroxide

OTHER SAFETY INFORMATION

  • Store at 20-25ºC (68-77ºF).
  • You may report serious adverse reactions to 1030 SW 34th Street, Suite A, Renton, WA 98057

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Full SizeFull Size

Trial Size Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Trial SizeTrial Size

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76144-621-012023-07-28C16284748780-19d75b9d0-4687-f424-e053-dadaa90a57cePaulas Choice CLEAR Anti-Redness Exfoliating Solution 2% Salicylic Acid, Extra Strength
76144-621-022023-07-28C16284748780-19d75b9d0-4687-f424-e053-dadaa90a57cePaulas Choice CLEAR Anti-Redness Exfoliating Solution 2% Salicylic Acid, Extra Strength
76144-621-002020-01-31C16284748780-19d75b9d0-4687-f424-e053-dadaa90a57cePaulas Choice CLEAR Anti-Redness Exfoliating Solution 2% Salicylic Acid, Extra Strength
76144-621-072020-01-31C16284748780-19d75b9d0-4687-f424-e053-dadaa90a57cePaulas Choice CLEAR Anti-Redness Exfoliating Solution 2% Salicylic Acid, Extra Strength

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76144-62176144-621-01, 76144-621-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE SODIUMMP1J8420LUIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM HYDROXIDE55X04QC32IIACT
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
c54e1173-70de-02d7-e053-2a95a90a76ee19af6116-0299-3cfb-e054-00144ff8d46c2022-01-06WarningsExact identifier
spl id: c54e1173-70de-02d7-e053-2a95a90a76ee
spl set id: 19af6116-0299-3cfb-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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