BenzEFoam

• Onset Dermatologics, LLC

• It is used to treat pimples (acne).

• If you have an allergy to benzoyl peroxide or any other part of BenzEFoam (benzoyl peroxide foam).
• 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 BenzEFoam with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Certain acne products that contain benzoyl peroxide or salicylic acid can rarely cause very bad and sometimes life-threatening allergic reactions or very bad irritation. Before first use, you may need to follow certain steps to make sure you do not have an allergic reaction. Use BenzEFoam as you were told by the doctor or read the package label. Talk with the doctor.
• Do not put on irritated skin.
• Do not put on sunburned skin.
• Do not leave this medicine on the skin longer than you have been told by the doctor.
• Use of other skin products while using BenzEFoam may cause more irritation.
• Talk with your doctor before you use other drugs or products on your skin.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Use care when putting on. It may bleach hair or colored fabric.
• This medicine may cause harm if swallowed. If this medicine is swallowed, call a doctor or poison control center right away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using BenzEFoam while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take BenzEFoam by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• If you get this medicine in any of these areas, rinse well with water.
• Wash your hands before and after use.
• Makeup may be used after the skin has dried.
• If you see BenzEFoam or white marks on your skin after you put it on, you may be using too much.
• It may take several weeks to see the full effects.
• To gain the most benefit, do not miss doses.
• Use as you have been told, even if your signs get better.
• Shake well before use.
• You will need to prime the pump before first use. You may also need to prime the pump if it has not been used for some time. Be sure you know when you need to prime the pump and how to do it. Talk with your doctor or pharmacist if you have questions.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Rinse well.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

Each gram of Benzefoam™ Emollient Foam contains 5.3% benzoyl peroxide in an aqueous based emollient foam vehicle containing BHT, C12-15 alkyl benzoate, cetearyl alcohol, citric acid, dimethicone, disodium EDTA, emulsifying wax, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, steareth-10. Also contains: Propellant HFA-134A (1,1,1,2-tetrafluoroethane).

Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14H10O4) is represented by the following structure:

 

General

If severe irritation develops, discontinue use and institute appropriate therapy.

Information for Patients

This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. Avoid contact with eyes, eyelids, lips, and mucous membranes. If accidental contact occurs, rinse with water. If excessive redness or irritation develops, discontinue use and consult your physician. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING OR DICOLORATION.

Carcinogenesis, Mutagenesis and 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.

Pregnancy

Category C. Animal reproduction studies have not been conducted with benzoyl peroxide. It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in the human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 12 have not been established.

Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.

Benzefoam Emollient Foam is supplied in a 60g (NDC 16781-194-60) aluminum can.

Store at room temperature: 59° - 77°F (15° - 25°C).

Protect from freezing.

Store upright.

Manufactured in USA For:

Onset Therapeutics

Cumberland, RI 02864

www.onsettx.com

888-713-8154

PATENT PENDING

P/N 2616-pf Rev. 0

 

PATIENT INFORMATION 

IMPORTANT: For use on skin only (topical use). 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. Contents under pressure. Do not puncture or incinerate container.

Read the Patient Information that comes with BenzefoamTM Emollient Foam before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of speaking with your doctor about your medical condition or your treatment.

WHAT IS Benzefoam EMOLLIENT FOAM?

Benzefoam Emollient Foam is a prescription medicine used on the skin (topical) to treat mild to moderate acne vulgaris. Benzefoam Emollient Foam contains benzoyl peroxide.

WHO SHOULD NOT USE Benzefoam EMOLLIENT FOAM?

Do not use Benzefoam Emollient Foam if you have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product.

WHAT SHOULD I TELL MY DOCTOR BEFORE USING Benzefoam EMOLLIENT FOAM?

Before using Benzefoam Emollient Foam, tell your doctor about all of your medical conditions, including if you:

• have any allergies. • are pregnant or planning to become pregnant. It is not known if Benzefoam Emollient Foam will harm your unborn baby. • are breastfeeding or plan to breast-feed. It is not known if Benzefoam Emollient Foam passes into your breast milk.

Tell your doctor about all the medicines and skin products you use. Other skin and topical acne products may increase the irritation of your skin when used with Benzefoam Emollient Foam. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

HOW SHOULD I USE Benzefoam EMOLLIENT FOAM?

• Use Benzefoam Emollient Foam exactly as prescribed. • Your doctor will tell you how long to use Benzefoam Emollient Foam. • Throw away (discard) any unused Benzefoam Emollient Foam after its expiration date. 

INSTRUCTIONS FOR APPLYING Benzefoam EMOLLIENT FOAM

• Before you apply Benzefoam Emollient Foam, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry. • For Proper Dispensing of Foam, Shake Vigorously and Tap Bottom of Can Before Each Use. • Prime Container Before Initial Use: Shake vigorously. After shaking, gently tap bottom of can onto palm of other hand or a solid surface at least 3 times. Remove cap. Hold can upright over sink. Avoid contact with hair, fabrics or carpeting as benzoyl peroxide will cause bleaching or discoloration. Firmly depress the actuator for 1 to 3 seconds until tab breaks and foam begins to dispense. (If foam does not dispense within 3 seconds: repeat entire process and depress the actuator again until foam begins to dispense.) • Before Each Use: Shake vigorously and gently tap bottom of can onto palm of other hand or a solid surface at least 3 times. • During Use: Holding can upright, dispense Benzefoam Emollient Foam into palm of hand and apply to affected area once daily, or as directed by a physician. For facial acne, use a dollop the size of a marble. For acne on either the back or chest, use a dollop the size of a whole walnut. Rub in until completely absorbed. Wipe off any excess foam from actuator after use. • Caution:Benzefoam Emollient Foam may bleach hair or colored fabric. • Wash your hands with soap and water after applying Benzefoam Emollient Foam. • If Benzefoam is applied to the chest or back, wearing a white t-shirt may avoid bleaching of clothing. • Avoid getting Benzefoam Emollient Foam in your mouth, eyes, or nose, or on your lips. If this occurs, rinse the affected area with warm water. • Do not get Benzefoam Emollient Foam on cuts or open wounds. • Do not use Benzefoam Emollient Foam more frequently than prescribed by your doctor.

WHAT SHOULD I AVOID WHILE USING Benzefoam EMOLLIENT FOAM?

• Limit your time in sunlight. Avoid using tanning beds or sun lamps. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing, and a sunscreen with SPF 15 rating or higher. Your doctor can give you more information about why this is important. • Do not wash your face more than 2 to 3 times a day. Washing your face too often or scrubbing it may make your acne worse.

WHAT ARE POSSIBLE SIDE EFFECTS WITH Benzefoam EMOLLIENT FOAM?

Side effects with Benzefoam Emollient Foam include:

• Skin irritation. Stop using Benzefoam Emollient Foam and call your doctor if you have a skin rash or your skin becomes very red, itchy or swollen. Talk to your doctor about any side effect that bothers you or that does not go away.

This is not the only possible side effect with Benzefoam Emollient Foam. Call your doctor for medical advice about side effects. You may report side effects to Onset Therapeutics at 1-888-713-8154.

HOW SHOULD I STORE Benzefoam EMOLLIENT FOAM?

Store at room temperature: 59º - 77ºF (15º - 25ºC).

Do not expose to temperatures above 120°F (49°C)

Protect from freezing.

Store upright.

Keep Benzefoam Emollient Foam and all medicines out of the reach of children.

GENERAL INFORMATION ABOUT Benzefoam EMOLLIENT FOAM

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use Benzefoam for a condition for which it was not prescribed. Do not give Benzefoam Emollient Foam to other people, even if they have the same condition you have. This leaflet summarizes the most important information about Benzefoam Emollient Foam. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about Benzefoam Emollient Foam that is written for healthcare professionals. For more information about Benzefoam Emollient Foam, call 1-888-713-8154 or go to www.Benzefoam.com.

WHAT ARE THE INGREDIENTS IN Benzefoam EMOLLIENT FOAM?

Active Ingredients: benzoyl peroxide 5.3%

Inactive Ingredients: BHT, C12-15 alkyl benzoate, cetearyl alcohol, citric acid, dimethicone, disodium EDTA, emulsifying wax, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, steareth-10. Also contains: Propellant HFA-134a (1,1,1,2-tetrafluoroethane).

Manufactured in USA For:

Onset Therapeutics

Cumberland, RI 02864

www.onsettx.com

888-713-8154

PATENT PENDING

P/N 2616-pf Rev. 0

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Box of six 5 Gram Cans

NDC 16781-194-06

Rx Only

BenzefoamTM

EmollientFoam

benzoyl peroxide 5.3%

Delivered in DelevoTM Foam

The Science of ComplianceTM

For topical treatment of mild to moderate acne vulgaris

See enclosed full Prescribing Information

Onset THERAPEUTICS

Professional Samples

Enclosed: Six 5g Samples

Available in 60g Cans

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Can Label, 5 Grams

NDC16781-194-06

Rx Only

Professional Sample

Not for Sale

Net Weight 5g

BenzefoamTM

EmollientFoam

benzoyl peroxide 5.3%

Delivered in DelevoTM Foam

The Science of ComplianceTM

Manufactured in USA For:

Onset Therapeutics

Cumberland, RI 02864

(888) 713-8154

www.onsettx.com

Expiration Date and Lot Code on bottom of can

PATENT PENDING P/N 2135 Rev. 0

Sample may not dispense entire contents.

Benzefoam  benzoyl peroxide aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16781-194 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 5.3 g  in 100 g

Inactive Ingredients Ingredient Name Strength GLYCERIN   PROPYLENE GLYCOL   CETOSTEARYL ALCOHOL   DIMETHICONE   SODIUM CITRATE   METHYLPARABEN   PROPYLPARABEN   EDETATE DISODIUM   BUTYLATED HYDROXYTOLUENE   CITRIC ACID MONOHYDRATE   WATER

Packaging # Item Code Package Description 1 NDC:16781-194-06 6 CAN in 1 BOX 1 5 g in 1 CAN 2 NDC:16781-194-60 1 CAN in 1 BOX 2 60 g in 1 CAN 3 NDC:16781-194-96 1 CAN in 1 BOX 3 100 g in 1 CAN

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 09/18/2009

Labeler - Onset Dermatologics LLC (793223707)

Registrant - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Operations
Onset Dermatologics LLC		793223707	MANUFACTURE(16781-194)

Revised: 06/2015   Onset Dermatologics LLC

Applies to benzoyl peroxide topical: topical bar, topical cream, topical foam, topical gel/jelly, topical liquid, topical lotion, topical pad, topical soap, topical solution

Along with its needed effects, benzoyl peroxide topical (the active ingredient contained in BenzEFoam) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking benzoyl peroxide topical:

Less common or rare

• Painful irritation of skin, including burning, blistering, crusting, itching, severe redness, or swelling
• skin rash

Incidence not known

• Difficult breathing
• fainting
• hives
• itching
• swelling of the eyes, face, lips, or tongue
• tightness in the throat

Get emergency help immediately if any of the following symptoms of overdose occur while taking benzoyl peroxide topical:

Symptoms of overdose

• Burning, itching, scaling, redness, or swelling of skin (severe)

Some side effects of benzoyl peroxide topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Dryness or peeling of the skin (may occur after a few days)
• feeling of warmth, mild stinging, and redness of the skin