DELOS Benzoyl peroxide Benzoyl Peroxide Benzoyl Peroxide 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 chemical structure Tube Label Box Label
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW 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
- HOW 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
Overview
INDICATIONS & USAGE Delos™ (3.5% benzoyl peroxide) lotion is indicated for the topical treatment of acne vulgaris.
Indications & Usage
INDICATIONS & USAGE Delos™ (3.5% benzoyl peroxide) lotion is indicated for the topical treatment of acne vulgaris.
Dosage & Administration
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.
Warnings & Precautions
WARNINGS When using this product, avoid unnecessary sun exposure and use a sunscreen.
Contraindications
These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.
Adverse Reactions
Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
Purpose
PURPOSE 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:
Keep Out of Reach of Children
KEEP OUT OF REACH OF CHILDREN Keep out of reach of children.
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