FDA.reportPublic FDA data

Benzoyl Acne Wash -2.5% Benzoyl Peroxide

Manufacturer
Only Yourx, Inc.
Effective date
2020-01-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:25

Label at a glance#

ProductBenzoyl Acne Wash -2.5% Benzoyl Peroxide
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions: use 1 to 3 times daily for oily skin and scalp; apply with fingertips, using circular motion; gently scrub into a lather; rinse off thoroughly with warm water; if going outside, use a sunscreen

WARNINGS SECTION

Warnings: For External Use Only

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Sodium C14-16 Alpha Olefin Sulfonate, Disodium Cocoamyphodiacetate, Glycerin, Ethoxydiglycol, Cocoamidopropyl Betaine, Acrylates C10-20 Alkyl Acrylates Crosspolymer, Disodium EDA, Potassium Sorbate, Polysorbate 20, Sodium Hydroxide, Polyacrylmide, C13-14 Isoparaffin, Laureth-7, Ethylhexylglycerin, Phenoxyethanol

INDICATIONS & USAGE SECTION

Uses: treats acne and helps prevent new acne blemishes from forming; kills acne bacteria

OTC - PURPOSE SECTION

Treats acne and prevents new acne blemishes from forming

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Benzoyl Peroxide 2.5%

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

OTC - ASK DOCTOR SECTION

Consult a doctor: if excessive irritation occurs

OTHER SAFETY INFORMATION

Other Information: store at room temperature; keep tightly closed

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benzoyl Acne Wash -2.5%Benzoyl Acne Wash -2.5%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
845836benzoyl peroxide 2.5 % Medicated Liquid SoapPSN2
845836benzoyl peroxide 25 MG/ML Medicated Liquid SoapSCD2
845836benzoyl peroxide 2.5 % Medicated Liquid 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
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70367-009-042022-07-29C16284748780-1e4f33bdf-a017-d8a0-e053-dadaa90a6e4e77468c7b-1906-c4fa-e053-2991aa0a8f06
70367-009-082022-07-29C16284748780-1e4f33bdf-a017-d8a0-e053-dadaa90a6e4e77468c7b-1906-c4fa-e053-2991aa0a8f06
70367-009-752022-07-29C16284748780-1e4f33bdf-a017-d8a0-e053-dadaa90a6e4e77468c7b-1906-c4fa-e053-2991aa0a8f06

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70367-009-04Benzoyl Acne Wash -2.5% Benzoyl Peroxide120 mL in 1 TUBESOAP1202
70367-009-08Benzoyl Acne Wash -2.5% Benzoyl Peroxide240 mL in 1 TUBESOAP2402
70367-009-75Benzoyl Acne Wash -2.5% Benzoyl Peroxide22.2 mL in 1 TUBESOAP22.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70367-009BENZOYL ACNE WASH -2.5% BENZOYL PEROXIDE (BENZOYL PEROXIDE) SOAP [ONLY YOURX, INC.]2Legacy NDC, 3 package rows20200124_77468c7b-1906-c4fa-e053-2991aa0a8f06.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70367-00970367-009-04, 70367-009-08, 70367-009-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
POLYSORBATE 207T1F30V5YHIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
GLYCERINPDC6A3C0OXIACT
ETHOXYDIGLYCOL BEHENATEN76ISC4ZZOIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
(C10-C30)ALKYL METHACRYLATE ESTERXH2FQZ38D8IACT
MAGNESIUM DISODIUM EDTANDT563S5VZIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
SODIUM HYDROXIDE55X04QC32IIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT

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
9cd5703c-a84e-955b-e053-2995a90a87af77468c7b-1906-c4fa-e053-2991aa0a8f062020-01-23WarningsExact identifier
spl id: 9cd5703c-a84e-955b-e053-2995a90a87af
spl set id: 77468c7b-1906-c4fa-e053-2991aa0a8f06

Reported adverse events (FAERS/openFDA)#

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