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NDC 00536-1055-57 Rugby Benzoyl Peroxide 50 mg/mL Details
Rugby Benzoyl Peroxide 50 mg/mL
Rugby Benzoyl Peroxide is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories, Inc.. The primary component is BENZOYL PEROXIDE.
MedlinePlus Drug Summary
Benzoyl peroxide is used to treat mild to moderate acne.
Related Packages: 00536-1055-57Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
| NDC | 00536-1055 |
|---|---|
| Product ID | 0536-1055_7dd13a35-c9e7-4a4c-a562-a79cf5b66aeb |
| Associated GPIs | 90050010004010 |
| GCN Sequence Number | 005813 |
| GCN Sequence Number Description | benzoyl peroxide GEL (GRAM) 5 % TOPICAL |
| HIC3 | L5A |
| HIC3 Description | KERATOLYTICS |
| GCN | 22931 |
| HICL Sequence Number | 002470 |
| HICL Sequence Number Description | BENZOYL PEROXIDE |
| Brand/Generic | Brand |
| Proprietary Name | Rugby Benzoyl Peroxide |
| Proprietary Name Suffix | Acne Medication |
| Non-Proprietary Name | Benzoyl Peroxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | BENZOYL PEROXIDE |
| Labeler Name | Rugby Laboratories, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333D |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00536-1055-57 (00536105557)
| NDC Package Code | 0536-1055-57 |
|---|---|
| Billing NDC | 00536105557 |
| Package | 1 TUBE in 1 CARTON (0536-1055-57) / 90 mL in 1 TUBE |
| Marketing Start Date | 2019-10-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL de9ac9fe-b6af-45b7-bbf2-70c47f45885b Details
Warnings
For external use only
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.
Directions
Other information
PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton
INGREDIENTS AND APPEARANCE
| RUGBY BENZOYL PEROXIDE
ACNE MEDICATION
benzoyl peroxide gel |
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| Labeler - Rugby Laboratories, Inc. (079246066) |
| Registrant - Garcoa, Inc. (103039178) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Garcoa, Inc. | 036464697 | MANUFACTURE(0536-1055) | |
Revised: 1/2022
Document Id: 7dd13a35-c9e7-4a4c-a562-a79cf5b66aeb
Set id: de9ac9fe-b6af-45b7-bbf2-70c47f45885b
Version: 5
Effective Time: 20220114