Sodaphos may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sodium Phosphate Monobasic dihydrate (a derivative of Sodium Phosphate) is reported as an ingredient of Sodaphos in the following countries:
International Drug Name Search
Alendronsäure Arcana may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Alendronsäure Arcana in the following countries:
International Drug Name Search
Romifidine Hydrochloride may be available in the countries listed below.
Romifidine Hydrochloride (BANM) is also known as Romifidine (Rec.INN)
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Actipiril may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of Actipiril in the following countries:
International Drug Name Search
G4 may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of G4 in the following countries:
International Drug Name Search
Diacort may be available in the countries listed below.
Diflorasone 17α,21-diacetate (a derivative of Diflorasone) is reported as an ingredient of Diacort in the following countries:
International Drug Name Search
BP 7% Wash is indicated for use in the topical treatment of acne vulgaris.
BP 7% Wash should be used once or twice daily on the affected areas, or as directed by a physician. Wet skin areas to be treated. Liberally apply, BP 7% Wash by massaging gently into skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry. If excessive drying occurs, rinse the cleanser off sooner or use less often.
Benzoyl peroxide 7% topical preparation
BP 7% Wash should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product.
KEEP OUT OF REACH OF CHILDREN. When using this product, avoid unnecessary sun exposure and use a sunscreen.
General: For external use only. Avoid contact with eyes and mucous membranes. If severe irritation develops, discontinue use and institute appropriate therapy. Once irritation clears, treatment may often be resumed with less frequent application.
Information for the Patient: Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING OR DISCOLORATION. If excessive irritation develops, discontinue use and consult your physician.
Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov.medwatch.
The use of tretinoin and hydroquinone topical preparations should be avoided when using this product.
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. 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 below the age of 12 have not been established.
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.
BP 7% Wash is a topical preparation containing benzoyl peroxide as the active ingredient for use in the treatment of acne vulgais. Each mL of BP 7% Wash contains 70mg of benzoyl peroxide in an emulsion base consisting of: 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.
Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic.
The exact mechanism 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 absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine. There is no evidence of systemic toxicity in humans caused by benzoyl peroxide.
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.
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved other | 08/01/2009 | ||
| Labeler - River's Edge Pharmaceuticals, LLC (133879135) |
