Captopril/Hydrochlorothiazide EG may be available in the countries listed below.
Captopril is reported as an ingredient of Captopril/Hydrochlorothiazide EG in the following countries:
Hydrochlorothiazide is reported as an ingredient of Captopril/Hydrochlorothiazide EG in the following countries:
International Drug Name Search
Medotaxime may be available in the countries listed below.
Cefotaxime sodium salt (a derivative of Cefotaxime) is reported as an ingredient of Medotaxime in the following countries:
International Drug Name Search
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:
The exact method of action of benzoyl peroxide in acne vulgaris is not known. Benzoyl peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes. This action, combined with the mild keratolytic effect of benzoyl peroxide, is believed to be responsible for its usefulness in acne. Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.
Benzefoam Emollient Foam is indicated for use in the topical treatment of mild to moderate acne vulgaris.
Benzefoam Emollient Foam should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product. Discontinue use if hypersensitivity is observed.
FOR EXTERNAL USE ONLY. Not For Ophthalmic Use. When using this product, avoid unnecessary sun exposure and use a sunscreen. Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120°F (49°C).
If severe irritation develops, discontinue use and institute appropriate therapy.
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.
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.
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.
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.
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.
If excessive scaling, erythema or edema occurs, the use of this preparation 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.
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. Wash hands with soap and water after applying Benzefoam Emollient Foam.
Frequency of use should be adjusted to obtain the desired clinical response. Gentle cleansing of the affected areas prior to application of Benzefoam Emollient Foam may be beneficial.
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:
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?
INSTRUCTIONS FOR APPLYING Benzefoam EMOLLIENT FOAM
WHAT SHOULD I AVOID WHILE USING Benzefoam EMOLLIENT FOAM?
WHAT ARE POSSIBLE SIDE EFFECTS WITH Benzefoam EMOLLIENT FOAM?
Side effects with Benzefoam Emollient Foam include:
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.
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part333D | 09/18/2009 | |
| Labeler - Onset Dermatologics LLC (793223707) |
| Registrant - Onset Dermatologics LLC (964275155) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Onset Dermatologics LLC | 793223707 | MANUFACTURE | |
Cefazolina Fabra may be available in the countries listed below.
Cefazolin sodium salt (a derivative of Cefazolin) is reported as an ingredient of Cefazolina Fabra in the following countries:
International Drug Name Search
Mildin may be available in the countries listed below.
Loratadine is reported as an ingredient of Mildin in the following countries:
International Drug Name Search
Ametop may be available in the countries listed below.
Tetracaine is reported as an ingredient of Ametop in the following countries:
Tetracaine hydrochloride (a derivative of Tetracaine) is reported as an ingredient of Ametop in the following countries:
International Drug Name Search
Flumazenilo Baggerman Farmanet may be available in the countries listed below.
Flumazenil is reported as an ingredient of Flumazenilo Baggerman Farmanet in the following countries:
International Drug Name Search
Terbutrop Guayacolato may be available in the countries listed below.
Guaifenesin is reported as an ingredient of Terbutrop Guayacolato in the following countries:
International Drug Name Search
Generic Name: quazepam (KWAY ze pam)
Brand Names: Doral
Quazepam is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Quazepam affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia).
Quazepam is used to treat insomnia symptoms, such as trouble falling or staying asleep.
Quazepam may also be used for other purposes not listed in this medication guide.
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking quazepam and talk with your doctor about another treatment for your sleep disorder.
Before taking quazepam, tell your doctor if you have any breathing problems, kidney or liver disease, or a history of depression, mental illness, suicidal thoughts, or addiction to drugs or alcohol.
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking quazepam and talk with your doctor about another treatment for your sleep disorder.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely take quazepam.
asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;
kidney or liver disease;
a history of depression, mental illness, suicidal thoughts or behavior; or
a history of drug or alcohol addiction.
The sedative effects of quazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking quazepam.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Your insomnia symptoms may return when you stop using quazepam, especially during the first day or two. You may also have unpleasant withdrawal symptoms such as vomiting, stomach pain, muscle cramps, sweating, shaky or unpleasant feeling, or seizure (convulsions). Talk to your doctor about how to avoid withdrawal symptoms when you stop using quazepam.
Keep track of how many tablets have been used from each new bottle of this medicine. Benzodiazepines are drugs of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.
Since quazepam is taken as needed, you are not likely to be on a dosing schedule. Take quazepam only when you have time for several hours of sleep.
Overdose symptoms may include extreme drowsiness, confusion, and fainting or coma.
worsening insomnia;
confusion, anxiety, slurred speech, unusual thoughts or behavior;
hallucinations, agitation, aggression;
weak or shallow breathing;
fast or pounding heartbeats;
muscle stiffness in your tongue, jaw, or neck;
problems with urination; or
jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
daytime drowsiness (or during hours when you are not normally sleeping);
amnesia or forgetfulness;
muscle weakness, lack of balance or coordination;
dizziness, vision problems;
nightmares;
headache, blurred vision, depressed mood;
feeling nervous, excited, or irritable;
impotence, loss of interest in sex;
mild itching or skin rash;
nausea, diarrhea, stomach pain, loss of appetite; or
dry mouth, increased thirst.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all other medications you use, especially:
bupropion (Wellbutrin, Zyban);
cyclophosphamide (Cytoxan, Neosar);
efavirenz (Sustiva);
irinotecan (Camptosar);
promethazine (Phenergan); or
selegiline (Eldepryl, Emsam, Zelapar).
This list is not complete and there may be other drugs that can interact with quazepam. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
See also: Doral side effects (in more detail)
