FDA.reportPublic FDA data

PCA SKIN Intensive Clarity Treatment

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 00:40:23

Label at a glance#

ProductPCA SKIN Intensive Clarity Treatment
Active ingredientSALICYLIC ACID
Label structure6 sections

Indications and uses

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

Dosage and administration

Cleanse 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 daily or every other day.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid (2.0%)     

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne.  Helps keep skin clear of new acne pimples, blackheads and/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 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Cleanse 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 daily or every other day.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, PEG-12 Glyceryl Dimyristate, Cyclopentasiloxane, Isododecane, Niacinamide, Butylene Glycol, Dimethicone, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Alcohol, Isoamyl Laurate, Glyceryl Stearate, PEG-100 Stearate, Sodium Polyacrylate,
Polysilicone-11, Bakuchiol, Caprylic/Capric Triglyceride, Maltodextrin, Phenoxyethanol, Coco-Caprylate/Caprate, Hexyl Resorcinol, Ethylhexyl Stearate, Retinol, Ethyl Linoleate, Polysorbate 20, Hexylresorcinol, Dipotassium Glycrrhizinate, Caprylyl Glycol, Trideceth-6, Xanthan Gum, Chlorphenesin, Pentylene Glycol, Isoamyl Cocoate, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Sodium Citrate, Disodium EDTA, Decyl Glucoside, Myristoyl Nonapeptide-3, Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Intensive Clarity Treatment UC 2024Intensive Clarity Treatment 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68726-359-01PCA SKIN Intensive Clarity Treatment29.5 g in 1 TUBEGEL29.511
68726-359-02PCA SKIN Intensive Clarity Treatment1 in 1 CARTONGEL111
68726-359-03PCA SKIN Intensive Clarity Treatment2 g in 1 TUBEGEL211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68726-359PCA SKIN INTENSIVE CLARITY TREATMENT (SALICYLIC ACID) GEL [CP SKIN HEALTH GROUP, INC.]11Current NDC, Legacy NDC, 3 package rows20241206_7bd6edc0-941e-492d-8b3c-4e8b3425f929.zip

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68726-35968726-359-01, 68726-359-02, 68726-359-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PEG-12 GLYCERYL DIMYRISTATEVS4W16AQ3XIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ISODODECANEA8289P68Y2IACT
NIACINAMIDE25X51I8RD4IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIMETHICONE92RU3N3Y1OIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ISOAMYL LAURATEM1SLX00M3MIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
WATER059QF0KO0RIACT
BAKUCHIOLOT12HJU3ARIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
MALTODEXTRIN7CVR7L4A2DIACT
PHENOXYETHANOLHIE492ZZ3TIACT
COCO-CAPRYLATE4828G836N6IACT
RETINOLG2SH0XKK91IACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
ETHYL LINOLEATEMJ2YTT4J8MIACT
HEXYLRESORCINOLR9QTB5E82NIACT
POLYSORBATE 207T1F30V5YHIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
CAPRYLYL GLYCOL00YIU5438UIACT
XANTHAN GUMTTV12P4NEEIACT
CHLORPHENESINI670DAL4SZIACT
TRIDECETH-63T5PCR2H0CIACT
PENTYLENE GLYCOL50C1307PZGIACT
ISOAMYL COCOATE14OG46E98EIACT
SYRINGA VULGARIS FLOWER9V5O040S3WIACT
SODIUM CITRATE1Q73Q2JULRIACT
EDETATE DISODIUM7FLD91C86KIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MYRISTOYL PENTAPEPTIDE-4PMA59A699XIACT
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
PCA SKIN Intensive Clarity TreatmentSALICYLIC ACIDCP Skin Health Group, Inc.7bd6edc0-941e-492d-8b3c-4e8b3425f9292024-12-03WarningsExact identifier
ndc (package): 68726-359-03
ndc (package): 68726-359-01
ndc (package): 68726-359-02
ndc (product): 68726-359
ndc11 (package): 68726035902
ndc11 (package): 68726035901
ndc11 (package): 68726035903
spl id: 2865a2cd-cdfb-d03b-e063-6394a90aa7d2
spl set id: 7bd6edc0-941e-492d-8b3c-4e8b3425f929

Reported adverse events (FAERS/openFDA)#

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