FDA.reportPublic FDA data

Milbar Laboratories

Manufacturer
Milbar Laboratories | Milbar Labs, Inc.
Effective date
2024-04-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:46

Label at a glance#

ProductMilbar Laboratories
Active ingredientBENZOYL PEROXIDE
Label structure5 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

WarningsWarningsWarning Section

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

OTC - WHEN USING SECTION

UsesUsesUses

Purpose

OTC - PURPOSE SECTION

PurposePurpose

INDICATIONS & USAGE SECTION

Indications and usageIndications and usage

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient SectionActive Ingredient SectionActive Ingredient Section

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

DOSAGE & ADMINISTRATION SECTION

Dosage and administrationDosage and administration

B-Prox 10 Anti-Blemish wash

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN1
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD1
142034benzoyl peroxide 10 % Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57577-531-01Milbar Laboratories236 mL in 1 BOTTLE, DISPENSINGRINSE2361
57577-531-02Milbar Laboratories1 in 1 BOXRINSE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57577-531MILBAR LABORATORIES RINSE [MILBAR LABORATORIES]12 package rows20240724_155ae2a0-4d4d-84c3-e063-6394a90abfdc.zip

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
57577-53157577-531-01, 57577-531-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PROPANEDIOL5965N8W85TIACT
ARTEMISIA VULGARIS TOP OIL72Q967Y48VIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DI-2-HEXYL SODIUM SULFOSUCCINATE772Y8KZU65IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM METABISULFITE4VON5FNS3CIACT
BOERHAVIA DIFFUSA ROOTKR0SR09KYLIACT
SODIUM HYDROXIDE55X04QC32IIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 0.5%)YY2HMJ9NZFIACT
LAMINARIA DIGITATA15E7C67EE8IACT
EPILOBIUM ANGUSTIFOLIUM WHOLEC278QS9YBTIACT
SODIUM SULFATE0YPR65R21JIACT
EPILOBIUM FLEISCHERI WHOLE8E2KLS8J8KIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
155ae2a0-4d4e-84c3-e063-6394a90abfdc155ae2a0-4d4d-84c3-e063-6394a90abfdc2024-04-05WarningsExact identifier
spl id: 155ae2a0-4d4e-84c3-e063-6394a90abfdc
spl set id: 155ae2a0-4d4d-84c3-e063-6394a90abfdc

Reported adverse events (FAERS/openFDA)#

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