Histigo may be available in the countries listed below.
Betahistine dimesilate (a derivative of Betahistine) is reported as an ingredient of Histigo in the following countries:
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Doc Cefuroxime may be available in the countries listed below.
Cefuroxime is reported as an ingredient of Doc Cefuroxime in the following countries:
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PMS-Glyburide may be available in the countries listed below.
Glibenclamide is reported as an ingredient of PMS-Glyburide in the following countries:
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Theracap 131 may be available in the countries listed below.
Sodium Iodide is reported as an ingredient of Theracap 131 in the following countries:
Theophylline is reported as an ingredient of Theracap 131 in the following countries:
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Catenol may be available in the countries listed below.
Atenolol is reported as an ingredient of Catenol in the following countries:
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DESCRIPTION: BPO 9% Foaming Cloths are topical preparations containing benzoyl peroxide for use in the treatment of acne vulgaris.Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14H10O4) is represented by the following chemical structure:
BPO 3% and 6% Foaming Cloths contain, respectively, benzoyl peroxide 3% and 6% as the active ingredient in a cream vehicle containing: cetostearyl alcohol, hydrogenated castor oil, cocamidopropyl betaine, PEG-14M, methyl paraben, mineral oil, purified water, sodium lauryl sulfate, potassium choride, glycolic acid, imidurea, sodium PCA liquid, cornstarch, titanium dioxide, sodium hydroxide, glycerine, dimethyl isosorbide.
CLINICAL PHARMACOLOGY: The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.
INDICATIONS: BPO 9% Foaming Cloths are indicated for the topical treatment of acne vulgaris.
CONTRAINDICATIONS: These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.
WARNINGS: When using this product, avoid unnecessary sun exposure and use a sunscreen.
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep container tightly closed.
Keep out of reach of children.
PRECAUTIONS: General - For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.
Information for patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.
Carcinogenesis, Mutagenesis, Impairment of Fertility - Data from several studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility.
PREGNANCY: Teratogenic Effects - Pregnancy Category C. - Animal reproduction studies have not been conducted with benzoyl peroxide. It is 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. There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child.
NURSING MOTHERS: It is not known whether this drug is excreted in 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 have not been established.
ADVERSE REACTIONS:Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
OVERDOSAGE: 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.
DOSAGE AND ADMINISTRATION: Wash affected areas once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10–20 seconds. Avoid eyes or mucous membranes. Rinse thoroughly and pat dry.
If drying occurs, it may be controlled by rinsing sooner or using less often. Throw away cloth. Do not flush.
HOW SUPPLIED: BPO 9% Foaming Cloths are available in boxes of 60 cloths (3.2g), (NDC 42192-128-60).
Store at controlled room temperature, 15 degree - 25 degree C (59 degree - 77 degree F).
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.
MANUFACTURED FOR: Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
1-800-541-4802
NDC 42192-128-60
BPO 9% Foaming Cloths
Rx only
Net weight 3.2 g each
Acella
PHARMACEUTICALS, LLC
Contents: benzoyl peroxide USP 9% as an active ingredient in a cream vehicle containing cetostearyl alcohol, hydrogenated castor oil, cocamidopropyl betaine, PEG-14M, methyl paraben, mineral oil, purified water, sodium lauryl sulfate, potassium choride, glycolic acid, imidurea, sodium PCA liquid, cornstarch, titanium dioxide, sodium hydroxide, glycerine, dimethyl isosorbide.
Directions: Wash affecte areas with BPO 9% Foaming cloths once or twice daily, or as directed by your physician.
1. Wet face with water.
2. Wet cloth with a little water and work into a full lather.
3. Cleanse face wuth cloth for 10 - 20 seconds, avoiding eyes and mucous
membrances.
4. Rinse thoroughly and pat dry.
5. Discard cloth. Do not flush.
If drying occurs, It may be controlled by rinsing cleanser off sooner or using
less often.
Precautions: See Package insert for complete Precautions and Prescribing information. For external use only.
Avoid contat with eyes, eyelids, lips ad mucous membranes. If accidental contact occurs, rinse with water, Contact with any colored material (Including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.
WARNINGS: Keep out of reach of children. When using this product, avoid unnecessary sun exposure and use a sunscreen.
Store at 15 Degree - 25 Degree Centigrade (59 Degree - 77 Degree F).
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Please see package insert for more information.
MANUFACTURED FOR: Acella Pharmaceuticals, LLC
Alpharetta, GA 30009
1-800-541-4802
Rx Only
60 foaming cloths - Net weight 3.2 g each
Acella
Pharmaceuticals, LLC
NDC 42192-128-60
BPO 9% Foaming Cloths
Contents: benzoyl peroxide USP 9% as an active ingredient in a cream vehicle containing cetostearyl alcohol, hydrogenated castor oil, cocamidopropyl betaine, PEG-14M, methyl paraben, mineral oil, purified water, sodium lauryl sulfate, potassium choride, glycolic acid, imidurea, sodium PCA liquid, cornstarch, titanium dioxide, sodium hydroxide, glycerine, dimethyl isosorbide.
Directions: Wash affecte areas with BPO 9% Foaming cloths once or twice daily, or as directed by your physician.
1. Wet face with water.
2. Wet cloth with a little water and work into a full lather.
3. Cleanse face wuth cloth for 10 - 20 seconds, avoiding eyes and mucous
membrances.
4. Rinse thoroughly and pat dry.
5. Discard cloth. Do not flush.
If drying occurs, It may be controlled by rinsing cleanser off sooner or using
less often.
Precautions: See Package insert for complete Precautions and Prescribing information. For external use only.
Avoid contat with eyes, eyelids, lips ad mucous membranes. If accidental contact occurs, rinse with water, Contact with any colored material (Including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.
Warnings: KEEP OUT OF REACH OF CHILDREN. When using this product, avoid unnecessary sun exposure and use a sunscreen.
Store at 15 degree - 25 degree Centigrade (59 degree - 77 degree F).
NDC 42192-128-60
BPO 9% Foaming Cloths
Rx Only
60 foaming cloths - Net weight 3.2 g each
Acella
PHARMACEUTICALS, LLC
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product. No representation is made as to generic status or bioequivalency. Please see package insert for more information.
MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
1-800-541-4802
Rev.0510v1
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 08/18/2010 | ||
| Labeler - Acella Pharmaceuticals, LLC (825380939) |
In the US, CYSTADANE (betaine systemic) is a member of the drug class nutraceutical products and is used to treat Nonalcoholic Fatty Liver Disease.
US matches:
Betaine is reported as an ingredient of CYSTADANE in the following countries:
Betaine hydrochloride (a derivative of Betaine) is reported as an ingredient of CYSTADANE in the following countries:
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Treatment of edema (swelling) associated with heart, kidney, or liver failure, or conditions in which there is excess body water. The injection is used when a rapid decrease of swelling is desired or when a tablet cannot be taken. It is also used alone or with other medicines to treat high blood pressure. It may also be used to treat certain conditions as determined by your doctor.
Demadex Solution is a loop diuretic. It works by making the kidneys eliminate larger amounts of electrolytes (especially sodium and potassium salts) and water than normal (diuretic effect).
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Demadex Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Demadex Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Demadex Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Demadex Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Demadex Solution.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; dizziness or lightheadedness when sitting up or standing; excessive urination; headache; increased cough; nasal inflammation; nausea.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; diarrhea; dry mouth or unusual thirst; fever, chills, or persistent sore throat; hearing loss or ringing in the ears; loss of appetite; muscle pain or cramps; rapid or irregular heartbeat; rectal bleeding; red, swollen, blistered, or peeling skin; restlessness; unusual bruising or bleeding; unusual tiredness or weakness; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Demadex side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; dizziness; dizziness or lightheadedness when sitting up or standing; dry mouth; excessive urination followed by a decrease in amount of urine, muscle cramps, weakness, and/or rapid or irregular heartbeat.
Store Demadex Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not freeze. Store away from heat, moisture, and light. Keep Demadex Solution out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Demadex Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
