FDA Label for Rugby Benzoyl Peroxide Acne Medication
View Indications, Usage & Precautions
Rugby Benzoyl Peroxide Acne Medication Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150
Active Ingredient
Benzoyl peroxide 5%
Purpose
Acne treatment
Use
for the treatment of acne
Warnings
For external use only
Otc - Do Not Use
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
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
Principal Display Panel - 42.5 G Tube Carton
NDC 0536-1055-56
Rugby®
Acne Medication
Benzoyl Peroxide Gel USP, 5%
5
Net Wt 1.5 oz (42.5 g)
* Please review the disclaimer below.