Rugby ® 10% Benzoyl Peroxide Gel

Manufacturer: NuCare Pharmaceuticals,Inc.
Effective date: 2024-06-10
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:13:32

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).

Contacts and useful links#

PhoneLabel contact1-800-645-2158

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne medication

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, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, 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 -

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
486131	benzoyl peroxide 10 % Topical Gel	PSN	4
486131	benzoyl peroxide 0.1 MG/MG Topical Gel	SCD	4
486131	benzoyl peroxide 10 % Topical Gel	SY	4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d9d61457-6a5a-41fc-b418-e5479a2904b7	Product name	2	20230303
32012d5c-25ac-49c7-9d4c-1313177fff7c	Product name	1	20230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
3f45980c-c196-47e5-0e5e-48b7c57327c5	Product name	5	20200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-4393-1	2024-06-11	C162847	48780-1	ba0f9c33-33f6-a910-e053-dadaa90a0b85	Rugby ® 10% Benzoyl Peroxide Gel
68071-4393-1	2023-01-30	C162847	48780-1	ba0f9c33-33f6-a910-e053-dadaa90a0b85	Rugby ® 10% Benzoyl Peroxide Gel
68071-4393-1	2021-02-16	C162847	48780-1	ba0f9c33-33f6-a910-e053-dadaa90a0b85	Rugby ® 10% Benzoyl Peroxide Gel
68071-4393-1	2021-01-29	C162847	48780-1	ba0f9c33-33f6-a910-e053-dadaa90a0b85	Rugby ® 10% Benzoyl Peroxide Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4393-1	Rugby Benzoyl PeroxideAcne Medication	42.5 mL in 1 BOX	GEL	42.5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4393	RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240613_69bd4f4c-017a-7422-e053-2991aa0aa655.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1056-25	GM - Gram	0536-1056	2a64a8e8-d3f8-4d3e-8404-a7c5b4b53d3b	1	2020-05-08
0536-1056-56	GM - Gram	0536-1056	3717c77a-6c91-45fe-b18d-d0fe79552242	1	2015-03-03

Products#

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

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

Rugby Benzoyl Peroxide Acne Medication
Benzoyl Peroxide
CARBOXYMETHYLCELLULOSE SODIUM
EDETATE DISODIUM
LAURETH-4
SODIUM HYDROXIDE
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68071-4393	68071-4393-1
0536-1056

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
LAURETH-4	6HQ855798J	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT
BENZOYL PEROXIDE	W9WZN9A0GM	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rugby Benzoyl Peroxide Acne Medication	BENZOYL PEROXIDE	NuCare Pharmaceuticals,Inc.	69bd4f4c-017a-7422-e053-2991aa0aa655	2024-06-10	Warnings	Exact identifier ndc (package): 68071-4393-1 ndc (product): 68071-4393 ndc11 (package): 68071439301 spl id: 1a8b5000-7731-1eda-e063-6394a90ae8c1 spl set id: 69bd4f4c-017a-7422-e053-2991aa0aa655
Rugby Benzoyl Peroxide Acne Medication	BENZOYL PEROXIDE	Rugby Laboratories	5cf3da87-ed50-4791-8f71-1b572f3b8f43	2024-02-09	Warnings	Exact identifier ndc (product): 0536-1056

Reported adverse events (FAERS/openFDA)#

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