FDA.reportPublic FDA data

Rugby ® 2.5% Benzoyl Peroxide Gel Acne Medication MGC

Manufacturer
Guangzhou Danting Bath&Body Care Industry Co. Ltd | Medical Group Care LLC
Effective date
2026-04-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:53:21

Label at a glance#

ProductRugby Benzoyl Peroxide Acne Medication
Active ingredientBENZOYL PEROXIDE
Label structure9 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 2.5%

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 
  • are sensitive to benzoyl peroxide.

When using this product

OTC - WHEN USING SECTION

  • 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.

Stop use and consult a doctor if

OTC - STOP USE SECTION

irritation becomes severe

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

aluminum hydroxide, carbomer, disodium EDTA, glycerin, sodium hydroxide, titanium dioxide, water, zinc oxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-306-9136

You may also report serious side effects to this phone
number
Mon-Fri, 9:00 AM - 5:00 PM Eastern Time.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BPO 2.5BPO 2.5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308689benzoyl peroxide 2.5 % Topical GelPSN2
308689benzoyl peroxide 0.025 MG/MG Topical GelSCD2
308689benzoyl peroxide 2.5 % Topical GelSY2

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
75376-466-25Rugby Benzoyl PeroxideAcne Medication1 in 1 CARTONGEL12
75376-466-25Rugby Benzoyl PeroxideAcne Medication60 g in 1 TUBEGEL602

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75376-46675376-466-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZIACT
CARBOMER0A5MM307FCIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0b9ebf-e3a7-6fab-e063-6394a90afded2026-04-09WarningsExact identifier
ndc (package): 75376-466-25
ndc (product): 75376-466
ndc11 (package): 75376046625
spl id: 4f0b9ec7-d71b-6e68-e063-6394a90aa3f0
spl set id: 4f0b9ebf-e3a7-6fab-e063-6394a90afded

Reported adverse events (FAERS/openFDA)#

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