FDA.reportPublic FDA data

Paulas Choice

Manufacturer
Prime Enterprises, Inc.
Effective date
2023-04-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:32:30

Label at a glance#

ProductPaulas Choice Anti-Redness
Active ingredientSALICYLIC ACID
Label structure11 sections

Dosage and administration

After cleansing, cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product skin irritation and dryness is more liketly to occur if you use another ttopical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation occurs or gets worse.

Directions

DOSAGE & ADMINISTRATION SECTION

  • After cleansing, cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water(Aqua), Methylpropanediol, Butylene Glycol, Polysorbate 20, Camellia Oleifera (Green Tea) Leaf Extract, Sodium Hydroxide, Tetrasodium EDTA

Questions or comments?

OTC - QUESTIONS SECTION

Call 1.800.831.4088 (U.S. and Canada)

Mon-Fri 6AM-6PM PT | Sat-Sun 8AM-4:30OM PT

Principal Display Label - 118 mL Paula's Choice

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

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
58443-062058443-0620-4

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
SODIUM HYDROXIDE55X04QC32IIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
EDETATE SODIUMMP1J8420LUIACT
METHYLPROPANEDIOLN8F53B3R4RIACT

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
fa2e5b1b-f3a1-11fe-e053-6394a90a4988fa2e549d-8f6d-d89b-e053-6294a90ad0562023-04-25WarningsExact identifier
spl id: fa2e5b1b-f3a1-11fe-e053-6394a90a4988
spl set id: fa2e549d-8f6d-d89b-e053-6294a90ad056

Reported adverse events (FAERS/openFDA)#

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