FDA.reportPublic FDA data

Dermaharmony 5% Benzoyl Peroxide

Manufacturer
D3 Development, Inc. | Vanguard Soap, LLC.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:47:51

Label at a glance#

ProductDermaharmony 5% Benzoyl Peroxide Cleansing Bar
Active ingredientBENZOYL PEROXIDE
Label structure11 sections

Storage and handling

Other information Store in a dry place between 59-86°F (15-30°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzoyl peroxide 5%

OTC - PURPOSE SECTION

Purpose

Acne medication

INDICATIONS & USAGE SECTION

Use

for the management of acne

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not useif you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

OTC - WHEN USING SECTION

When using this product

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • 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.
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

OTC - STOP USE SECTION

Stop use and ask a doctor ifirritation becomes severe.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • using warm water, wash affected area for 1-2 minutes
  • rinse thoroughly and pat dry with a clean towel
  • start with 1 application daily, then gradually increase to 2-3 times daily if needed or as directed by a doctor
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor

STORAGE AND HANDLING SECTION

Other information

Store in a dry place between 59-86°F (15-30°C)

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sodium cocoyl isethionate, stearic acid, coconut fatty acid, sodium isethionate, water. coco glucoside, cetearyl alcohol & ceteareth-20, iron oxides (red and yellow), lactic acid

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in USA of U.S. and imported ingredients.

NDC Code: 71819-013-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermaharmony

5% Benzoyl Peroxide

Cleansing Bar

FOR THE TREATMENT OF ACNE

Reduces: pimples-blemishes-whiteheads-blackheads

NET WT 4 OZ (113G)

71819-013 Benzoyl Peroxide Final71819-013 Benzoyl Peroxide Final

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308692benzoyl peroxide 5 % Medicated Bar SoapPSN2
308692benzoyl peroxide 0.05 MG/MG Medicated Bar SoapSCD2
308692benzoyl peroxide 5 % Medicated Bar SoapSY2

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-013-04Dermaharmony 5% Benzoyl PeroxideCleansing Bar113 g in 1 CARTONSOAP1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-013DERMAHARMONY 5% BENZOYL PEROXIDE CLEANSING BAR (BENZOYL PEROXIDE) SOAP [D3 DEVELOPMENT, INC.]2Current NDC, Legacy NDC, 1 package rows20241222_c7ceae0d-3215-1f83-e053-2995a90a60bc.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71819-01371819-013-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
LACTIC ACID33X04XA5ATIACT
COCO GLUCOSIDEICS790225BIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
STEARIC ACID4ELV7Z65APIACT
COCONUT ACID40U37V505DIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM ISETHIONATE3R36J71C17IACT
WATER059QF0KO0RIACT
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
Dermaharmony 5% Benzoyl Peroxide Cleansing BarBENZOYL PEROXIDED3 Development, Inc.c7ceae0d-3215-1f83-e053-2995a90a60bc2024-12-20WarningsExact identifier
ndc (package): 71819-013-04
ndc (product): 71819-013
ndc11 (package): 71819001304
spl id: 29bac9b0-d65e-c3a2-e063-6394a90a17fb
spl set id: c7ceae0d-3215-1f83-e053-2995a90a60bc

Reported adverse events (FAERS/openFDA)#

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