PCA SKIN BPO Cleanser

Manufacturer
CP Skin Health Group, Inc.
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
31
Source
full-release
Hydrated at
2026-06-01 00:40:26

Label at a glance#

ProductPCA SKIN BPO Cleanser
Active ingredientBENZOYL PEROXIDE
Label structure6 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:       Benzoyl Peroxide (5.0%)   

OTC - PURPOSE SECTION

Purpose: Acne Cleanser

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings: When using this product,avoid unnecessary sun exposure and use a sunscreen.

____________________________________________________________________________

For external use only.

____________________________________________________________________________

Using other topical acne drugs at the same time or immediately following the sue of this product may increase dryness or irritation of the skin.  If this occurs, only one drug should be sued unless directed by a physician.

_________________________________________________________________________________________

Do not use in or near the eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Apply a small amount of cleanser to damp skin with fingertips and massage into a light foaming lather.
  • Wash in a gentle circular motion.
  • Rinse with warm (not hot) water and pat dry.
  • Start with one treatment daily or as directed by a physician.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water/Aqua/Eau, Gluconolactone, Sodium C14-16 Olefin Sulfonate, Aminomethyl Propanol, Glycerin, Cocamidopropyl Betaine, Aloe Babadensis Leaf Juice, Sodium PCA, Tocopheryl Acetate,  Allantoin, Panthenol, Phytic Acid, Triticum Vulgare (Wheat) Germ Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Anthemis Nobilis Flower Extract, Vitis Vinifera (Grape) Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Arnica Montana Flower Extract, Algae Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate-13, Caprylyl Glycol, Polisobutene, Ehtylhexylglycerin, Hexylene Glycol, Polysorbate 20, Butylene Glycol, Phenoxyethanol, Citrus Grandis (Grapefruit) Peel Oil.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BPO Cleanser UC 7oz 2024BPO Cleanser UC 7oz 2024

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308696benzoyl peroxide 5 % Medicated Liquid SoapPSN31
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCD31
308696benzoyl peroxide 5 % Medicated Liquid SoapSY31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68726-168-01PCA SKIN BPO Cleanser206.5 mL in 1 BOTTLEGEL206.531
68726-168-02PCA SKIN BPO Cleanser30 mL in 1 BOTTLEGEL3031
68726-168-04PCA SKIN BPO Cleanser1 in 1 CARTONGEL131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68726-168PCA SKIN BPO CLEANSER (BENZOYL PEROXIDE) GEL [CP SKIN HEALTH GROUP, INC.]31Current NDC, Legacy NDC, 3 package rows20241206_eb55cc26-cf47-4e9e-b7a8-23ef82aecce2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM3
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM3
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4N3
ALLANTOININACTIVE INGREDIENT344S277G0Z3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X3
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626Q3
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZW3
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA3
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U3
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OG3
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y73
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX3
CUCUMBERINACTIVE INGREDIENTYY7C30VXJT3
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P3
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POT3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
GRAPEINACTIVE INGREDIENT6X543N684K3
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J3
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
PHYTIC ACIDINACTIVE INGREDIENT7IGF0S7R8I3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH3
WATERINACTIVE INGREDIENT059QF0KO0R3
WHEAT GERMINACTIVE INGREDIENTYR3G369F5A3

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68726-16868726-168-01, 68726-168-04, 68726-168-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 44 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
12 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii+route
8 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSPONGE / TOPICALADJ PHExact identifier — unii+route
12 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii+route
8 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii+route
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii+route
8 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JGEL / TOPICAL280 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTCLOTH / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JGEL / TOPICAL280 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
12 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii+route
8 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
4 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
12 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTCLOTH / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JGEL / TOPICAL280 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii+route
8 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSPONGE / TOPICALADJ PHExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSPONGE / TOPICALADJ PHExact identifier — unii+route
12 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTCLOTH / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
4 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
4 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTCLOTH / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii+route
8 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii+route
8 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
12 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JGEL / TOPICAL280 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSPONGE / TOPICALADJ PHExact identifier — unii+route
12 equally ranked IID candidates

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 BPO CleanserBENZOYL PEROXIDECP Skin Health Group, Inc.eb55cc26-cf47-4e9e-b7a8-23ef82aecce22024-12-03WarningsExact identifier
ndc (package): 68726-168-04
ndc (package): 68726-168-01
ndc (package): 68726-168-02
ndc (product): 68726-168
ndc11 (package): 68726016802
ndc11 (package): 68726016801
ndc11 (package): 68726016804
spl id: 2865b5b3-737d-f3bc-e063-6394a90a6299
spl set id: eb55cc26-cf47-4e9e-b7a8-23ef82aecce2

Reported adverse events (FAERS/openFDA)#

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