FDA.reportPublic FDA data

PCA Gel

Manufacturer
CP Skin Health Group, Inc
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:40:21

Label at a glance#

ProductPCA Gel
Active ingredientSALICYLIC ACID
Label structure6 sections

Indications and uses

For the treatment of acne Helps keep skin clear of new acne pimples, blackheads or whiteheads

Dosage and administration

Clean the skin thoroughly before applying this product 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%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne
  • Helps keep skin clear of new acne pimples, blackheads or whiteheads

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 medication at a time.
Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the skin thoroughly before applying this product
  • 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

Alcohol, Butylene Glycol, Cellulose, Denatonium Benzoate, Ethoxydiglycol, Ethyl Linoleate, Hexylresorcinol, Hydroxyethylcellulose, Isopentyldiol, Mandelic Acid, Pentylene Glycol, Polyacrylate Crosspolymer-6, Polyglyceryl-10 Dioleate, Polyglyceryl-10 Dipalmitate, Potassium Hydroxide, Sodium Acetate, t-Butyl Alcohol, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acne Gel UC 2024Acne Gel UC 2024

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
346298salicylic acid 2 % Topical GelPSN11
346298salicylic acid 0.02 MG/MG Topical GelSCD11
346298salicylic acid 2 % Topical GelSY11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68726-445-01PCA Gel29.5 mL in 1 BOTTLEGEL29.511
68726-445-02PCA Gel1 in 1 CARTONGEL111
68726-445-03PCA Gel7.3 mL in 1 TUBEGEL7.311

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68726-445PCA GEL (SALICYLIC ACID) GEL [CP SKIN HEALTH GROUP, INC]11Current NDC, Legacy NDC, 3 package rows20241206_396b4675-451f-48b2-b139-19508434e0fe.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
68726-44568726-445-01, 68726-445-02, 68726-445-03

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
ALCOHOL3K9958V90MIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POWDERED CELLULOSESMD1X3XO9MIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
ETHYL LINOLEATEMJ2YTT4J8MIACT
HEXYLRESORCINOLR9QTB5E82NIACT
ISOPENTYLDIOL19NOL5474QIACT
MANDELIC ACIDNH496X0UJXIACT
PENTYLENE GLYCOL50C1307PZGIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
POLYGLYCERYL-10 OLEATE55C81W76DHIACT
POLYGLYCERYL-10 DIPALMITATE84VD0IA2S6IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
SODIUM HYDROXIDE55X04QC32IIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
SALICYLIC ACIDO414PZ4LPZACTIB
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
PCA GelSALICYLIC ACIDCP Skin Health Group, Inc396b4675-451f-48b2-b139-19508434e0fe2024-12-03WarningsExact identifier
ndc (package): 68726-445-03
ndc (package): 68726-445-02
ndc (package): 68726-445-01
ndc (product): 68726-445
ndc11 (package): 68726044503
ndc11 (package): 68726044502
ndc11 (package): 68726044501
spl id: 2865d888-37e6-e35a-e063-6394a90a2bc2
spl set id: 396b4675-451f-48b2-b139-19508434e0fe

Reported adverse events (FAERS/openFDA)#

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