FDA.reportPublic FDA data

Rugby Benzoyl Peroxide Wash

Manufacturer
Rugby Laboratories | Garcoa, Inc. | SV Labs Toronto Corporation
Effective date
2024-03-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:37:47

Label at a glance#

ProductRugby Benzoyl Peroxide Wash Acne Medication
Active ingredientBenzoyl Peroxide
Label structure11 sections

Dosage and administration

shake well Wet area to be cleansed Sensitive Test for a New User . Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow directions stated below one to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse ...

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

  • shake well
  • Wet area to be cleansed
  • Sensitive Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow directions stated below
  • one to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry
  • 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, cetyl alcohol, disodium EDTA, disodium laureth sulfosuccinate, glycerin, glyceryl stearate, laureth-7, magnesium aluminum silicate, PEG-100 stearate, propylene glycol, sodium coco-sulfate, sodium lauroamphoacetate, water, xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by:
RUGBY® LABORATORIES
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 237 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®

NDC 0536-1351-42

Benzoyl Peroxide
Topical Wash USP

10%

Acne Medication

  • Helps to keep skin clear
  • Helps dry oily skin
  • Helps clear acne pimples

NET WT 8.5 OZ (237g)

PRINCIPAL DISPLAY PANEL - 237 g Bottle Label
PRINCIPAL DISPLAY PANEL - 237 g Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN5
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD5
142034benzoyl peroxide 10 % Medicated Liquid SoapSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130305361351427GTIN-13: 0305361351427
EAN-13: 0305361351427
GTIN-12: 305361351427
UPC-A: 305361351427
GTIN storage (14 digits): 00305361351427		rugby-benzoyl-peroxide-wash-acne-medication-10-1.jpg

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
0536-1351-42Rugby Benzoyl Peroxide WashAcne Medication237 g in 1 BOTTLE, DISPENSINGLOTION2375

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1351-42GM - Gram0536-135113da9630-a524-4136-8b9b-99a4a27551c012022-05-04

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-13510536-1351-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzoyl PeroxideW9WZN9A0GMACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
Cetyl Alcohol936JST6JCNIACT
EDETATE DISODIUM7FLD91C86KIACT
Disodium Laureth SulfosuccinateD6DH1DTN7EIACT
GlycerinPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
Laureth-7Z95S6G8201IACT
Magnesium Aluminum Silicate6M3P64V0NCIACT
PEG-100 StearateYD01N1999RIACT
Propylene Glycol6DC9Q167V3IACT
Sodium Coco-Sulfate3599J29ANHIACT
Sodium LauroamphoacetateSLK428451LIACT
Water059QF0KO0RIACT
Xanthan GumTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-03-01monthly-update2026-06-03 17:40:43

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
8ff759dd-f84d-4844-9777-74494baa1ae4d0cb59bc-3c35-4861-bdff-87b27a0e1d132024-03-01WarningsExact identifier
spl id: 8ff759dd-f84d-4844-9777-74494baa1ae4
spl set id: d0cb59bc-3c35-4861-bdff-87b27a0e1d13

Reported adverse events (FAERS/openFDA)#

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