package Delos Lotion Generic Name: benzoyl peroxide Dosage Form: lotion Side Effects Dosage Professional Interactions Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. Delos (3.5% benzoyl peroxide) lotion with Novasome Technology Rx Only FOR EXTERNAL USE ONLY Slideshow Acne Advice: Skin Care Solutions For Both Teens and Adults Alike Delos Lotion Description Delos (3.5% benzoyl peroxide) lotion is a topical preparation containing benzoyl peroxide, for use in the treatment of acne vulgaris, and patented Novasome encapsulation technology to help provide continuous hydration and moisturization to minimize the appearance of skin dryness. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic agent. Benzoyl peroxide (C 14 H O 4 ) is represented by the following chemical structure: Delos (3.5% benzoyl peroxide) lotion contains benzoyl peroxide USP 3.5% as the active ingredient in a formulation consisting of: Allantoin, Aloe Barbadensis Leaf Juice, Butylene Glycol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cetyl Alcohol, Dimethicone, Edetate Disodium, Ethylene/Acrylic Acid Copolymer, Glycerin, Glycine Soya (Soybean) Sterols, Methylparaben, Phenoxyethanol, Propylparaben, Purified Water, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate, and Xanthan Gum. Delos Lotion - 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 & USAGE Delos (3.5% benzoyl peroxide) lotion is 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. 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 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 effect 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 used by 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 & ADMINISTRATION Apply Delos (3.5% benzoyl peroxide) lotion once or twice daily to cover affected areas, or as directed by your physician. Use after washing with a mild cleanser and water. How is Delos Lotion Supplied Delos (3.5% benzoyl peroxide) lotion is available in 45 g tube (NDC 49908-121-45). Store at controlled room temperature: 15 - 30 C (59 - 86 F). Manufactured for: Rochester Pharmaceuticals Rochester, NY 14625 Toll Free: 1-866-458-1772 www.RoshesterPharm.com www.DelosLotion.com August 2010 PACKAGE LABEL NDC 49908-121-45 For dermatologic use only - Not for ophthalmic use Rx only delos with Novasome Technology (3.5% benzoyl peroxide) lotion 1.5 oz (45 g) Each gram contains - Active: benzoyl peroxide 3.5%. Inactive: Allantoin, Aloe Barbadensis Leaf Juice, Butylene Glycol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cetyl Alcohol, Dimethicone, Edetate Disodium, Ethylene/Acrylic Acid Copolymer, Glycerin, Glycine Soya (Soybean) Sterols, Methylparaben, Phenoxyethanol, Propylparaben, Purified Water, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate, and Xanthan Gum. Usual dosage: Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes. See package insert for full prescribing information . Important: Do not use if seal has been punctured or is not visible. Store at 15 -30 C (59 -86 F) See crimp for lot no. and expiration date. Distributed by: Rochester Pharmaceuticals Rochester, NY 14625 www.RochesterPharm.com Rochester Pharmaceuticals NDC 49908-121-45 For dermatologic use only - Not for ophthalmic use Rx only delos with Novasome Technology (4.5% benzoyl peroxide) lotion 1.5 oz (45 g) Each gram contains - Active: benzoyl peroxide 3.5%. Inactive: Allantoin, Aloe Barbadensis Leaf Juice, Butylene Glycol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cetyl Alcohol, Dimethicone, Edetate Disodium, Ethylene/Acrylic Acid Copolymer, Glycerin, Glycine Soya (Soybean) Sterols, Methylparaben, Phenoxyethanol, Propylparaben, Purified Water, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate, and Xanthan Gum. Usual dosage: Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes. See package insert for full prescribing information . Important: Do not use if seal has been punctured or is not visible. Store at 15 -30 C (59 -86 F) See crimp for lot no. and expiration date. Distributed by: Rochester Pharmaceuticals Rochester, NY 14625 www.RochesterPharm.com Rochester Pharmaceuticals DELOS benzoyl peroxide lotion Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49908-121 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide 35 mg in 1 g Inactive Ingredients Ingredient Name Strength Allantoin Aloe Vera Leaf Butylene Glycol Medium-chain Triglycerides Cetostearyl Alcohol Cetearyl Glucoside Cetearyl Olivate Cetyl Alcohol Dimethicone Edetate Disodium Glycerin Methylparaben Phenoxyethanol Propylparaben Water Sorbitan Olivate Stearyl Alcohol Xanthan Gum Packaging # Item Code Package Description 1 NDC:49908-121-45 1 TUBE (TUBE) in 1 BOX 1 45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/01/2010 Labeler - Rochester Pharmaceuticals (069874500) Establishment Name Address ID/FEI Operations IGI LABORATORIES, INC. 011036910 MANUFACTURE Revised: 04/2012 Rochester Pharmaceuticals Next Interactions Print this page Add to My Med List More about Delos (benzoyl peroxide topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: topical acne agents Consumer resources Professional resources Delos Liquid (FDA) Other brands: BenzePro , PanOxyl , Peroderm 7 Wash , Triaz , ... +15 more Related treatment guides Acne Perioral Dermatitis} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical acne agents Related Drugs topical acne agents clindamycin topical , erythromycin topical , tretinoin topical , tetracycline topical , dapsone topical , Finacea Acne doxycycline , clindamycin topical , erythromycin topical , minocycline , tretinoin topical , tetracycline , dapsone topical , Accutane , Vibramycin , Retin-A , isotretinoin , More... Perioral Dermatitis metronidazole topical , clindamycin topical , MetroGel , benzoyl peroxide topical , Cleocin T , MetroCream , Noritate , Clindagel , Acne Treatment , MetroLotion , Oxy-10 , Evoclin , More... Delos Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } cutting-edge
did you know Delos Lotion really appropriate
EmoticonEmoticon