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.
Rugby ® 5% Benzoyl Peroxide Gel Acne Medication
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2024-07-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:16:02
Label at a glance#
ProductBenzoyl Peroxide Acne Medication
Active ingredientBENZOYL PEROXIDE
Label structure10 sections
Storage and handling
Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Benzoyl peroxide 5%
Purpose
Acne treatment
Use
for the treatment of acne
Warnings
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
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
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
Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).
Inactive ingredients
carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water
Questions or comments?
1-800-645-2158
SPL UNCLASSIFIED SECTION
Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150
PRINCIPAL DISPLAY PANEL -
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2307-5 | Benzoyl PeroxideAcne Medication | 42.5 mL in 1 TUBE | GEL | 42.5 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2307 | BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240726_b55acec6-5a4d-08b7-e053-2995a90a0f74.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-1055-25 | GM - Gram | 0536-1055 | f4c29262-6ad3-410a-b5be-9502dcc50fe4 | 1 | 2020-05-08 |
| 0536-1055-56 | GM - Gram | 0536-1055 | 363f9952-a5d1-4875-80bf-9625fb034d84 | 1 | 2017-05-03 |
| 0536-1055-57 | GM - Gram | 0536-1055 | 42bf1054-7b01-419a-bd06-67ee3fceb1d1 | 1 | 2020-07-13 |
Products#
Every source-derived product name is available through these pages.
- Benzoyl Peroxide Acne Medication
- Benzoyl Peroxide
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- EDETATE DISODIUM
- LAURETH-4
- SODIUM HYDROXIDE
- TITANIUM DIOXIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-2307 | 68071-2307-5 |
| 0536-1055 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Benzoyl Peroxide Acne Medication | BENZOYL PEROXIDE | NuCare Pharmaceuticals,Inc. | b55acec6-5a4d-08b7-e053-2995a90a0f74 | 2024-07-17 | Warnings | 68071-2307-5 68071-2307 68071230705 1d78819d-c76c-7ba4-e063-6394a90a404d b55acec6-5a4d-08b7-e053-2995a90a0f74 |
| Rugby Benzoyl Peroxide Acne Medication | BENZOYL PEROXIDE | Rugby Laboratories | de9ac9fe-b6af-45b7-bbf2-70c47f45885b | 2024-02-09 | Warnings | 0536-1055 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.