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.
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.
Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).
Drug Facts
Benzoyl peroxide 5%
Acne treatment
for the treatment of acne
For external use only
Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
n keep away from eyes, lips and mouth
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.
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.
Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).
carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water
1-800-645-2158
Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0536-1055-25 | Rugby Benzoyl PeroxideAcne Medication | 60 mL in 1 TUBE | GEL | 60 | 8 | |
| 0536-1055-25 | Rugby Benzoyl PeroxideAcne Medication | 1 in 1 CARTON | GEL | 1 | 8 | |
| 0536-1055-56 | Rugby Benzoyl PeroxideAcne Medication | 42.5 mL in 1 TUBE | GEL | 42.5 | 8 | |
| 0536-1055-56 | Rugby Benzoyl PeroxideAcne Medication | 1 in 1 CARTON | GEL | 1 | 8 | |
| 0536-1055-57 | Rugby Benzoyl PeroxideAcne Medication | 90 mL in 1 TUBE | GEL | 90 | 8 | |
| 0536-1055-57 | Rugby Benzoyl PeroxideAcne Medication | 1 in 1 CARTON | GEL | 1 | 8 |
| 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 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Benzoyl Peroxide | ACTIVE INGREDIENT | W9WZN9A0GM | 1 | |
| Benzoyl Peroxide | ACTIVE MOIETY | W9WZN9A0GM | 1 | |
| Carboxymethylcellulose Sodium | INACTIVE INGREDIENT | K679OBS311 | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| Laureth-4 | INACTIVE INGREDIENT | 6HQ855798J | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0536-1055 | 0536-1055-56, 0536-1055-25, 0536-1055-57 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Benzoyl Peroxide | W9WZN9A0GM | ACTIB |
| Carboxymethylcellulose Sodium, Unspecified | K679OBS311 | IACT |
| Edetate Disodium | 7FLD91C86K | IACT |
| Laureth-4 | 6HQ855798J | IACT |
| Sodium Hydroxide | 55X04QC32I | IACT |
| Titanium Dioxide | 15FIX9V2JP | IACT |
| Water | 059QF0KO0R | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | LOTION / TOPICAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION / TOPICAL | NA | ||
| Laureth-4 | LAURETH-4 | 6HQ855798J | GEL / TOPICAL | 60 mg | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYSTEM / TOPICAL | 1680 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / TOPICAL | 70 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION / TOPICAL | NA | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / TOPICAL | 24 mg | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYSTEM / TOPICAL | 1680 mg | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | LOTION / TOPICAL | NA | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | LOTION / TOPICAL | NA | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / TOPICAL | 24 mg | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GEL / DENTAL | 0.4 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / TOPICAL | 24 mg | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | LOTION / TOPICAL | NA | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / TOPICAL | 70 mg | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYSTEM / TOPICAL | 1680 mg | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GEL / DENTAL | 0.4 %w/w | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GEL / DENTAL | 0.4 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / TOPICAL | 70 mg | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GEL / DENTAL | 0.4 %w/w | ||
| Laureth-4 | LAURETH-4 | 6HQ855798J | GEL / TOPICAL | 60 mg | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION / TOPICAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYSTEM / TOPICAL | 1680 mg | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION / TOPICAL | NA | ||
| Laureth-4 | LAURETH-4 | 6HQ855798J | GEL / TOPICAL | 60 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / TOPICAL | 70 mg | ||
| Laureth-4 | LAURETH-4 | 6HQ855798J | GEL / TOPICAL | 60 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / TOPICAL | 24 mg |
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 |
|---|---|---|---|---|---|---|
| Rugby Benzoyl Peroxide Acne Medication | BENZOYL PEROXIDE | Rugby Laboratories | de9ac9fe-b6af-45b7-bbf2-70c47f45885b | 2024-02-09 | Warnings | 0536-1055-25 0536-1055-56 0536-1055-57 0536-1055 00536105556 00536105525 00536105557 bfe57b5b-90ae-4643-aa53-ce8dff70a6c3 de9ac9fe-b6af-45b7-bbf2-70c47f45885b |
Adverse event summaries are temporarily unavailable. Other product information remains available.