Rugby ® 10% Benzoyl Peroxide Gel

Manufacturer
A-S Medication Solutions
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 00:34:59

Label at a glance#

ProductRugby Benzoyl Peroxide Acne Medication
Active ingredientBENZOYL PEROXIDE
Label structure12 sections

Dosage and administration

clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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 ...

Storage and handling

keep tightly closed store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide USP 10%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only.

Do not use if you

OTC - DO NOT USE SECTION

  • have very sensitive
  • are sensitive to benzoyl peroxide

When using this product

OTC - WHEN USING SECTION

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with eyes, lips and mouth
  • avoid contact with hair or 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.
  • 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.

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • irritation becomes severe

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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 (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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 this product
  • if irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • keep tightly closed
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-1792

NDC: 50090-1792-0 42.5 mL in a TUBE / 1 in a CARTON

Benzoyl Peroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
486131benzoyl peroxide 10 % Topical GelPSN14
486131benzoyl peroxide 0.1 MG/MG Topical GelSCD14
486131benzoyl peroxide 10 % Topical GelSY14

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
50090-1792-02023-02-07C16284748780-1f386c649-cada-0266-e053-dadaa90a7c1aRugby ® 10% Benzoyl Peroxide Gel
50090-1792-02023-01-30C16284748780-1f386c649-cada-0266-e053-dadaa90a7c1aRugby ® 10% Benzoyl Peroxide Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1792-0Rugby Benzoyl Peroxide Acne Medication1 in 1 CARTONGEL114
50090-1792-0Rugby Benzoyl Peroxide Acne Medication42.5 mL in 1 TUBEGEL42.514

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1792RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 2 package rows20241108_98e1bf69-ef71-4e38-8357-54c60d9d03df.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1792-0GM - Gram50090-17923c752dbe-fd44-464d-9ad4-1ef34234ce8012018-09-05
0536-1056-25GM - Gram0536-10562a64a8e8-d3f8-4d3e-8404-a7c5b4b53d3b12020-05-08
0536-1056-56GM - Gram0536-10563717c77a-6c91-45fe-b18d-d0fe7955224212015-03-03

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-179250090-1792-0
0536-1056

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEA-S Medication Solutions98e1bf69-ef71-4e38-8357-54c60d9d03df2024-11-06WarningsExact identifier
ndc (package): 50090-1792-0
ndc (product): 50090-1792
ndc11 (package): 50090179200
spl id: 1e1a4348-27fb-4b9b-a3a6-901e5b0ae508
spl set id: 98e1bf69-ef71-4e38-8357-54c60d9d03df
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories5cf3da87-ed50-4791-8f71-1b572f3b8f432024-02-09WarningsExact identifier
ndc (product): 0536-1056

Reported adverse events (FAERS/openFDA)#

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