Rugby ® 5% Benzoyl Peroxide Gel Acne Medication

Manufacturer
Rugby Laboratories | Garcoa, Inc.
Effective date
2024-02-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:17:27

Label at a glance#

ProductRugby Benzoyl Peroxide Acne Medication
Active ingredientBenzoyl Peroxide
Label structure10 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

PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0536-1055-56

Rugby®

Acne Medication
Benzoyl Peroxide Gel USP, 5%

5

Net Wt 1.5 oz (42.5 g)

Principal Display Panel - 42.5 g Tube Carton
Principal Display Panel - 42.5 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308694benzoyl peroxide 5 % Topical GelPSN8
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD8
308694benzoyl peroxide 5 % Topical GelSY8

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1055-25Rugby Benzoyl PeroxideAcne Medication60 mL in 1 TUBEGEL608
0536-1055-25Rugby Benzoyl PeroxideAcne Medication1 in 1 CARTONGEL18
0536-1055-56Rugby Benzoyl PeroxideAcne Medication42.5 mL in 1 TUBEGEL42.58
0536-1055-56Rugby Benzoyl PeroxideAcne Medication1 in 1 CARTONGEL18
0536-1055-57Rugby Benzoyl PeroxideAcne Medication90 mL in 1 TUBEGEL908
0536-1055-57Rugby Benzoyl PeroxideAcne Medication1 in 1 CARTONGEL18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GM1
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GM1
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS3111
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
Laureth-4INACTIVE INGREDIENT6HQ855798J1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP1
WaterINACTIVE INGREDIENT059QF0KO0R1

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
0536-10550536-1055-56, 0536-1055-25, 0536-1055-57

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311LOTION / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
Laureth-4LAURETH-46HQ855798JGEL / TOPICAL60 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii+route
16 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii+route
16 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311LOTION / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311LOTION / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii+dosage form
16 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311LOTION / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii+route
16 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii+dosage form
16 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii+dosage form
16 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii+dosage form
16 equally ranked IID candidates
Laureth-4LAURETH-46HQ855798JGEL / TOPICAL60 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii+route
16 equally ranked IID candidates
Carboxymethylcellulose SodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
Laureth-4LAURETH-46HQ855798JGEL / TOPICAL60 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Laureth-4LAURETH-46HQ855798JGEL / TOPICAL60 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratoriesde9ac9fe-b6af-45b7-bbf2-70c47f45885b2024-02-09WarningsExact identifier
ndc (package): 0536-1055-25
ndc (package): 0536-1055-56
ndc (package): 0536-1055-57
ndc (product): 0536-1055
ndc11 (package): 00536105556
ndc11 (package): 00536105525
ndc11 (package): 00536105557
spl id: bfe57b5b-90ae-4643-aa53-ce8dff70a6c3
spl set id: de9ac9fe-b6af-45b7-bbf2-70c47f45885b

Reported adverse events (FAERS/openFDA)#

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