Rugby ® 5% Benzoyl Peroxide Gel Acne Medication

Manufacturer
A-S Medication Solutions
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 00:34:31

Label at a glance#

ProductRugby Benzoyl Peroxide Acne Medication
Active ingredientBENZOYL PEROXIDE
Label structure11 sections

Dosage and administration

Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day.

Storage and handling

Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 5%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

When using this product

OTC - WHEN USING SECTION

n keep away from eyes, lips and mouth

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor.
  • using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

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. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day.

Other information

STORAGE AND HANDLING SECTION

Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-1720

NDC: 50090-1720-0 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
308694benzoyl peroxide 5 % Topical GelPSN17
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD17
308694benzoyl peroxide 5 % Topical GelSY17

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1720-0Rugby Benzoyl Peroxide Acne Medication42.5 mL in 1 TUBEGEL42.517
50090-1720-0Rugby Benzoyl Peroxide Acne Medication1 in 1 CARTONGEL117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1720RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 2 package rows20241107_a86ae901-53d0-4bfd-808e-59d9a7bc5ef6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1720-0GM - Gram50090-17201746ecce-e7da-4fc4-bf3f-e2a8818e766d12018-08-13
0536-1055-25GM - Gram0536-1055f4c29262-6ad3-410a-b5be-9502dcc50fe412020-05-08
0536-1055-56GM - Gram0536-1055363f9952-a5d1-4875-80bf-9625fb034d8412017-05-03
0536-1055-57GM - Gram0536-105542bf1054-7b01-419a-bd06-67ee3fceb1d112020-07-13

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
50090-172050090-1720-0
0536-1055

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 Solutionsa86ae901-53d0-4bfd-808e-59d9a7bc5ef62024-11-06WarningsExact identifier
ndc (package): 50090-1720-0
ndc (product): 50090-1720
ndc11 (package): 50090172000
spl id: 47eabb5e-9335-4e9a-bb9b-90839ca26a4c
spl set id: a86ae901-53d0-4bfd-808e-59d9a7bc5ef6
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratoriesde9ac9fe-b6af-45b7-bbf2-70c47f45885b2024-02-09WarningsExact identifier
ndc (product): 0536-1055

Reported adverse events (FAERS/openFDA)#

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