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NDC 00536-1261-63 Rugby Benzoyl Peroxide Wash 100 mg/mL Details
Rugby Benzoyl Peroxide Wash 100 mg/mL
Rugby Benzoyl Peroxide Wash is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is BENZOYL PEROXIDE.
MedlinePlus Drug Summary
Benzoyl peroxide is used to treat mild to moderate acne.
Related Packages: 00536-1261-63Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
| NDC | 00536-1261 |
|---|---|
| Product ID | 0536-1261_5bb2d899-8018-43eb-87b7-dc5a11b62583 |
| Associated GPIs | 90050010000910 |
| GCN Sequence Number | 005820 |
| GCN Sequence Number Description | benzoyl peroxide CLEANSER 10 % TOPICAL |
| HIC3 | L5A |
| HIC3 Description | KERATOLYTICS |
| GCN | 22984 |
| HICL Sequence Number | 002470 |
| HICL Sequence Number Description | BENZOYL PEROXIDE |
| Brand/Generic | Generic |
| Proprietary Name | Rugby Benzoyl Peroxide Wash |
| Proprietary Name Suffix | Acne Medication |
| Non-Proprietary Name | Benzoyl Peroxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/mL |
| Substance Name | BENZOYL PEROXIDE |
| Labeler Name | Rugby Laboratories |
| 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 00536-1261-63 (00536126163)
| NDC Package Code | 0536-1261-63 |
|---|---|
| Billing NDC | 00536126163 |
| Package | 148 mL in 1 BOTTLE, DISPENSING (0536-1261-63) |
| Marketing Start Date | 2019-12-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 0e1ec762-6de3-47b1-9717-55f8f3e3ca7f 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
- shake well
- Wet area to be cleansed
- Sensitive Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow directions stated below
- one to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry
- 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 - 148 mL Bottle Label
INGREDIENTS AND APPEARANCE
| RUGBY BENZOYL PEROXIDE WASH
ACNE MEDICATION
benzoyl peroxide lotion |
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| Labeler - Rugby Laboratories (079246066) |
| Registrant - Garcoa, Inc. (036464697) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sigan Industries, Inc. | 255106239 | MANUFACTURE(0536-1261) | |
Revised: 1/2022
Document Id: 5bb2d899-8018-43eb-87b7-dc5a11b62583
Set id: 0e1ec762-6de3-47b1-9717-55f8f3e3ca7f
Version: 2
Effective Time: 20220124