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NDC 00536-1056-25 Rugby Benzoyl Peroxide 100 mg/mL Details
Rugby Benzoyl Peroxide 100 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: 00536-1056-25Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
| NDC | 00536-1056 |
|---|---|
| Product ID | 0536-1056_9d484819-3d46-43be-b3ee-fea6be3d3076 |
| Associated GPIs | 90050010004015 |
| GCN Sequence Number | 005810 |
| GCN Sequence Number Description | benzoyl peroxide GEL (GRAM) 10 % TOPICAL |
| HIC3 | L5A |
| HIC3 Description | KERATOLYTICS |
| GCN | 22930 |
| 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 | 100 |
| 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 00536-1056-25 (00536105625)
| NDC Package Code | 0536-1056-25 |
|---|---|
| Billing NDC | 00536105625 |
| Package | 1 TUBE in 1 CARTON (0536-1056-25) / 60 mL in 1 TUBE |
| Marketing Start Date | 2019-10-15 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.18456 |
| Pricing Unit | GM |
| Effective Date | 2023-12-20 |
| NDC Description | ACNE MEDICATION 10% GEL |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 5cf3da87-ed50-4791-8f71-1b572f3b8f43 Details
Warnings
For external use only.
When using this product
- 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.
Directions
- 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.
Inactive ingredients
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 60 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(0536-1056) | |
Revised: 1/2022
Document Id: 9d484819-3d46-43be-b3ee-fea6be3d3076
Set id: 5cf3da87-ed50-4791-8f71-1b572f3b8f43
Version: 6
Effective Time: 20220107