FDA.reportPublic FDA data

Rugby ® Acne Medication Benzoyl Peroxide Gel USP 2.5%

Manufacturer
Rugby Laboratories | Garcoa, Inc. | Sigan Industries INC
Effective date
2024-03-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:35:00

Label at a glance#

ProductRugby Acne Medication Benzoyl Peroxide
Active ingredientBenzoyl Peroxide
Label structure11 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.

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

  • 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

carbomer, chlorphenesin, disodium EDTA, ethylhexylglycerin, hydroxyl methylcellulose, laureth-4, phenoxyethanol, sodium hydroxide, water.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®

NDC 0536-1129-25

Acne Medication
Benzoyl Peroxide Gel USP

2.5%

  • Effective yet gentler on the
    skin than treatments with
    10% Benzoyl Peroxide
  • Helps to keep skin clear
  • Helps clear acne pimples

Greaseless, Vanishing Formula

NET WT 2.1 OZ (60 g)

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1129-25GM - Gram0536-1129cbc08e83-df23-45d5-8909-19603265ce7012020-07-13

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-11290536-1129-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzoyl PeroxideW9WZN9A0GMACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
ChlorphenesinI670DAL4SZIACT
Edetate Disodium7FLD91C86KIACT
Ethylhexylglycerin147D247K3PIACT
Hypromellose, Unspecified3NXW29V3WOIACT
Laureth-46HQ855798JIACT
PhenoxyethanolHIE492ZZ3TIACT
Sodium Hydroxide55X04QC32IIACT
Water059QF0KO0RIACT

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
000d6bc1-b7df-4d73-8e29-6ef480b31a3d2b2a7e51-263f-4d1c-8f01-c9914b5383132024-03-01WarningsExact identifier
spl id: 000d6bc1-b7df-4d73-8e29-6ef480b31a3d
spl set id: 2b2a7e51-263f-4d1c-8f01-c9914b538313

Reported adverse events (FAERS/openFDA)#

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