FDA.reportPublic FDA data

Clear Choice BP 8% Topical Acne Gel

Manufacturer
Dermastart Inc
Effective date
2024-02-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:44

Label at a glance#

ProductClear Choice BP 8 Topical Acne
Active ingredientBENZOYL PEROXIDE
Label structure7 sections

Dosage and administration

Apply over entire face or affected area. Dryness may occur, start with one daily application and increase as needed or as directed by your skincare professional. Avoid eye contact. Sunblock is recommended.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 8%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Indications:

INDICATIONS & USAGE SECTION

  • For the use of Acne
  • Prevents future Acne breakouts
  • Eliminates P-bacteria

Warnings:

WARNINGS SECTION

For external use only - DO NOT APPLY TO BROKEN SKIN

- When using this product,

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove. May bleach colored fabrics. Discontinue use if signs of rash or irritation appear.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children in case of accidental ingestion, contact a Poison Control Center or get medical help.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply over entire face or affected area. Dryness may occur, start with one daily application and increase as needed or as directed by your skincare professional. Avoid eye contact. Sunblock is recommended.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Purified Water, Certified Organic Aloe Vera Gel, Japanese Green Tea Extract, Vegetable Glycerin, Cetearyl Alcohol (and) Ceteareth-20, Benzoyl Peroxide, Caprylic/Capric Triglycerides, Thiotic (Alpha Lipoic) Acid, Cetyl Alcohol, Dexapanthenol (Vitamin B5), Vitamin E Acetate, Lecithin, Retinyl Palmitate (Vitamin A), Sodium Hyaluronate, NaPCA, Extracts of Corn Silk, Alpha Bisabolol (Chamomile), Comfrey Root and Centella Asiatica, Magnesium Ascorbyl Phosphate (Vitamin C), and Grapeseed Extract.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1.866.589.2949

dermastart.com

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label.jpgLabel.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308697benzoyl peroxide 8 % Topical GelPSN2
308697benzoyl peroxide 0.08 MG/MG Topical GelSCD2
308697benzoyl peroxide 8 % Topical GelSY2

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83722-001-002025-12-01C16284748780-13b156c62-294e-fb37-e063-e6dba90a4e07Clear Choice BP 8% Topical Acne Gel
83722-001-002025-07-29C16284748780-13b156c62-294e-fb37-e063-e6dba90a4e07Clear Choice BP 8% Topical Acne Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83722-001-00Clear Choice BP 8 Topical Acne60 mL in 1 TUBEGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83722-001CLEAR CHOICE BP 8 TOPICAL ACNE (BENZOYL PEROXIDE) GEL [DERMASTART INC]21 package rows20240217_a29273e7-e282-4dd2-b524-e6458461c82c.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83722-00183722-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETYL ALCOHOL936JST6JCNIACT
PANTOTHENIC ACID19F5HK2737IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VITAMIN A81G40H8B0TIACT
HYALURONATE SODIUMYSE9PPT4THIACT
CHAMOMILEFGL3685T2XIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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
10ce3a82-97cd-df83-e063-6394a90a36e9a29273e7-e282-4dd2-b524-e6458461c82c2024-02-07WarningsExact identifier
spl id: 10ce3a82-97cd-df83-e063-6394a90a36e9
spl set id: a29273e7-e282-4dd2-b524-e6458461c82c

Reported adverse events (FAERS/openFDA)#

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