DOSAGE & ADMINISTRATION SECTION.

Directions. Cleanse skin thoroughly before applying medication. Cover the entire affected area with thin layer 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once day.

INACTIVE INGREDIENT SECTION.

Inactive ingredients. carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water.

INDICATIONS & USAGE SECTION.

Use. for the treatment of acne.

OTC - ACTIVE INGREDIENT SECTION.

Active ingredient. Benzoyl peroxide 10%.

OTC - DO NOT USE SECTION.

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

OTC - PURPOSE SECTION.

Purpose. Acne medication.

OTC - QUESTIONS SECTION.

Questions or comments. 1-800-645-2158.

OTC - WHEN USING SECTION.

When using this product keep away from eyes, lips and mouthavoid unnecessary sun exposure and use sunscreenavoid 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 lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult 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 doctor.. avoid unnecessary sun exposure and use 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 lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult 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 doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 29.5 mL Tube Carton. NDC 0536-1058-75Rugby(R)Acne MedicationBenzoyl Peroxide Lotion USP, 10%101 fl oz (29.5 mL). PRINCIPAL DISPLAY PANEL 29.5 mL Tube Carton.

SPL UNCLASSIFIED SECTION.

Drug Facts.

STORAGE AND HANDLING SECTION.

Other information. Keep tightly closed. Avoid storing at extreme temperatures (below 40 and above 100 F).

WARNINGS SECTION.

Warnings. For external use only. Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.. When using this product keep away from eyes, lips and mouthavoid unnecessary sun exposure and use sunscreenavoid 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 lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult 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 doctor.. avoid unnecessary sun exposure and use 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 lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult 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 doctor.. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.