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
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
Active Ingredient
Benzoyl peroxide 10% USP
Purpose
Acne medication
Use
for the treatment of acne
Warnings
For external use only
Do Not Use This Medication If You
- have very sensitive skin
- are sensitive to benzoyl peroxide.
When Using This Product
- 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.
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the eyes, lips and mouth
- avoid contact with hair and 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 frequent or in a lower concentration.
Stop Use And Ask A Doctor If
- irritation becomes severe
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.
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.
Other Information
Keep tightly closed at room temperature.
Inactive Ingredients
carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water
Questions Or Comments?
1-800-645-2158
Principal Display Panel - 29.5 Ml Tube Carton
NDC 0536-1058-75
Rugby®
Acne Medication
Benzoyl Peroxide Lotion USP, 10%
10
1 fl oz (29.5 mL)
* Please review the disclaimer below.