BP Wash

• If you have an allergy to benzoyl peroxide or any other part of BP Wash (benzoyl peroxide wash and cleanser).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have very sensitive skin.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take BP Wash with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad skin irritation.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

If excessive scaling, erythema or edema occurs, the use of these preparations should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known. Benzoyl peroxide has not been found to be mutagenic (Ames Test). There are no published data indicating impairment of fertility.

BP 7% Wash is supplied as follows:
SIZE: 16 ounce bottle
NDC #: 68032-427-16

STORAGE CONDITIONS:
Store at controlled room temperature 15-30C (59-86F).
Protect from freezing.

GENERAL INFORMATION
Patients should be advised of the following:
•    Avoid contact with eyes, eyelids, lips, and mucous membranes while using benzoyl peroxide. If accidental contact occurs, rinse with water.
•    If excessive irritation develops, discontinue use and consult their physician.
•    When using this product, avoid unnecessary sun exposure and use a sunscreen.
•    Avoid contact with hair, fabrics, or carpeting as benzoyl peroxide will cause bleaching or discoloration.

ADVERSE REACTIONS
Patients should be informed that treatment with topical benzoyl peroxide may lead to adverse reactions that include allergic contact dermatitis and dryness.

EXCESSIVE USE OF TOPICAL BENZOYL PEROXIDE
Patients should be advised to discontinue use and consult their physician if excessive scaling, erythema, or edema occurs. Advise the use of cool compresses to hasten resolution of the adverse effects. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.

NDC 68032-427-16
Rx Only
BP 7% Wash
7% Benzoyl Peroxide
In a vehicle containing Aloe and Green Tea
TOPICAL ACNE THERAPY
Net Wt. 16 oz.

DIRECTIONS: Shake well before using. Wet areas to be treated and liberally apply BP 7% Wash by massaging gently into skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry. Avoid contact with eyes, eyelids, and lips.

ACTIVE INGREDIENT: Benzoyl peroxide 7%
INACTIVE INGREDIENTS: Aloe Barbedensis Leaf Extract, Carbomer, Cetyl Alcohol, Disodium Laureth Sulfosuccinate, PEG-100 Stearate, Glycerin, Camellia Oleifera Leaf (Green Tea) Extract, Octoxynol-13, Magnesium Aluminum Silicate, Propylene Glycol, Purified Water, PPG-14 Palmeth-60 Hexyl Dicarbamate, Xanthan Gum, Allantoin, Benzyl Alcohol, Glyceryl Stearate, Panthenol, Sodium Citrate, Sodium Hyaluronate, Triethanolamine.

WARNINGS:
KEEP OUT OF REACH OF CHILDREN.
For External Use Only.
When using this product, avoid unnecessary sun exposure and use a sunscreen. Benzoyl peroxide may bleach colored or dyed fabric.

See package insert for full prescribing information.

Store at controlled room temperature 15-30C (59-86F).
Protect from freezing.