FDA Label for Rugby Acne Medication Benzoyl Peroxide
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- DO NOT USE IF YOU
- WHEN USING THIS PRODUCT
- STOP USE AND CONSULT A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 60 G TUBE CARTON
Rugby Acne Medication Benzoyl Peroxide Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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 Drive, Suite 233
Livonia, MI 48152
Active Ingredient
Benzoyl Peroxide USP 2.5%
Purpose
Acne medication
Use
for the treatment of acne
Warnings
For external use only.
Do Not Use If You
- have very sensitive
- are sensitive to benzoyl peroxide
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.
Stop Use And Consult A Doctor If
- irritation becomes severe
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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) immediately.
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
- store at room temperature
Inactive Ingredients
carbomer, chlorphenesin, disodium EDTA, ethylhexylglycerin, hydroxyl methylcellulose, laureth-4, phenoxyethanol, sodium hydroxide, water.
Questions Or Comments?
1-800-645-2158
Principal Display Panel - 60 G Tube Carton
Rugby®
NDC 0536-1129-25
Acne Medication
Benzoyl Peroxide Gel USP
2.5%
- Effective yet gentler on the
skin than treatments with
10% Benzoyl Peroxide - Helps to keep skin clear
- Helps clear acne pimples
Greaseless, Vanishing Formula
NET WT 2.1 OZ (60 g)
* Please review the disclaimer below.