FDA.reportPublic FDA data

111 Medco Benzoyl Peroxide

Manufacturer
111 Medco
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:04:05

Label at a glance#

Product111 Medco Benzoyl Peroxide
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Storage and handling

Store at controlled room temperature 59° - 86°F (15° - 30°C) Other information

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzoyl peroxide 10%

OTC - PURPOSE SECTION

Purpose

Acne medication

INDICATIONS & USAGE SECTION

for the treatment of acne; helps prevent new acne blemishes from forming Use

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • if you have very sensitive skin
  • if you are sensitive to benzoyl peroxide

OTC - WHEN USING SECTION

When using 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
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • 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 consult a doctor if

  • irritation becomes severe.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • using warm water, wash the affected area for 1 to 2 minutes
  • rinse well and pat dry with a clean towel
  • because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, apply sunscreen after using the product
  • If irritation or sensitivity develops, stop use of both products and ask a doctor.

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59° - 86°F (15° - 30°C) Other information

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aqua, Cetearyl Alcohol, Decyl Glucoside, Dextrin, Glycerin, Sodium Chloride, Sodium Cocoyl Isethionate, Tetrasodium Glutamate Diacetate

SPL UNCLASSIFIED SECTION

MADE IN USA ​

Distributed by:

111MedCo, LLC

8 The Green, Suite 8178

Dover, DE 19901

info@111MedCo.com

www.111MedCo.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

111 Medco

10% BENZOYL PEROXIDE

FOR ACNE

cleansing bar

Net Wt 4 OZ (113 g)

111MedCo 10 Benzoyl Peroxide Soap Bar Label111MedCo 10 Benzoyl Peroxide Soap Bar Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308685benzoyl peroxide 10 % Medicated Bar SoapPSN9
308685benzoyl peroxide 0.1 MG/MG Medicated Bar SoapSCD9
308685benzoyl peroxide 10 % Medicated Bar SoapSY9

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
72811-137-112023-08-21C16284748780-10191ceaa-6b45-198a-e063-dbdaa90aec3e111Medco Benzoyl Peroxide Acne Cleansing Bar
72811-137-112023-07-28C16284748780-10191ceaa-6b45-198a-e063-dbdaa90aec3e111Medco Benzoyl Peroxide Acne Cleansing Bar

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72811-137-11111 Medco Benzoyl Peroxide113 g in 1 CARTONSOAP1139

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72811-137111 MEDCO BENZOYL PEROXIDE (BENZOYL PEROXIDE) SOAP [111 MEDCO]9Current NDC, Legacy NDC, 1 package rows20231213_8590214e-e5a7-8934-e053-2a91aa0a248b.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72811-13772811-137-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

Source Document#

Source XML · Source PDF

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
111 Medco Benzoyl PeroxideBENZOYL PEROXIDE111 Medco8590214e-e5a7-8934-e053-2a91aa0a248b2023-12-12WarningsExact identifier
ndc (package): 72811-137-11
ndc (product): 72811-137
ndc11 (package): 72811013711
spl id: 0c5ce71d-4764-65bd-e063-6294a90ad6da
spl set id: 8590214e-e5a7-8934-e053-2a91aa0a248b

Reported adverse events (FAERS/openFDA)#

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