with the intention to Rosaclear Generic Name: metronidazole Dosage Form: topical gel Side Effects Dosage Professional Interactions Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. Rosaclear SYSTEM Gentle Cleanser 6.7 fl. oz. (198 mL) Gentle Cleanser provides gentle yet effective cleansing and instantly dissolves excess oil, makeup, and other everyday impurities. Slideshow Looking Ahead: New Drug Approvals for 2017 Ingredients water (aqua), cocamidopropyl betaine, glycerin, aloe barbadensis leaf juice, sodium lauroyl oat amino acids, sodium laureth sulfate, sodium chloride, glycereth-7, prunus armeniaca (apricot) kernel oil, borago officinalis extract, salvia officinalis (sage) leaf extract, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, oleyl lactate, saponins, citric acid, tetrasodium EDTA, triethanolamine, ethoxydiglycol, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), Yellow 5 (CI 19140) Metronidazole Topical Gel USP, 0.75% NDC 62032-123-65 Net wt. 45 g Metronidazole Topical Gel USP, 0.75% is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. Each gram contains 7.5 mg of metronidazole, USP as the active ingredient with 0.8 mg of methylparaben, NF and 0.2 mg of propylparaben, NF as preservatives in a gel consisting of carbopol 980, NF; edetate disodium, USP; propylene glycol, USP; purified water, USP; and sodium hydroxide, NF FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE). RX ONLY. Store at 20 C 25 C (68 F 77 F) [see USP Controlled Room Temperature]. KEEP OUT OF REACH OF CHILDREN. Hydrating Complexion Corrector Net wt. 3 oz. (85 g) Hydrating Complexion Corrector is formulated for sensitive skin and skin prone to flushing, redness, and blotchiness. Daily use of the product will help reduce the appearance of redness. Ingredients water (aqua), titanium dioxide (CI 77891), isohexadecane, coco-caprylate/caprate, ethylhexyl palmitate, dipropylene glycol, PEG-6, propylene glycol, stearyl alcohol, isocetyl behenate, glyceryl stearate, PEG-100 stearate, glycerin, talc, dimethicone, C13-15 alkane, allantoin, aloe barbadensis leaf juice, bacopa monniera extract, hydrolyzed oat protein, avena sativa (oat) beta glucan, avena sativa (oat) kernel extract, sodium cocoyl amino acids, arnica montana flower extract, cupressus sempervirens seed extract, polygonatum multiflorum rhizome/root extract, glycyrrhiza glabra (licorice) root extract, lavandula angustifolia (lavender) flower/leaf/stem extract, sea whip extract (gorgonia extract), tocopheryl acetate, butylene glycol, ethylhexyl stearate, bisabolol, cetyl alcohol, polysorbate 60, sarcosine, pentylene glycol, hydroxyethylcellulose, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, magnesium aluminum silicate, xanthan gum, magnesium aspartate, potassium aspartate, potassium sorbate, diazolidinyl urea, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, alumina, silica, mica, iron oxides (CI 77491, CI 77492, CI 77499) Store at controlled room temperature: 20 C 25 C (68 F 77 F). Do not freeze. Obagi, the Obagi logo, and Rosaclear are registered trademarks of OMP, Inc. Distributed by OMP, Inc., Long Beach, CA 90806 2012 Obagi Medical Products, Inc. All rights reserved. www.obagi.com Made in USA 40726012Z 7260 PRINCIPAL DISPLAY PANEL - Kit Carton NDC# 62032-507-65 OBAGI MEDICAL Rosaclear SYSTEM Gentle Cleanser Metronidazole Topical Gel USP, 0.75% Rx Only Hydrating Complexion Corrector Established Pharmacological Class Substance Pharmacological Class Rosaclear SYSTEM GENTLE CLEANSER Cleansing (cold creams, cleansing lotions, liquids, and pads) Rosaclear SYSTEM HYDRATING COMPLEXION CORRECTOR Face and Neck (excluding shaving preparations) Rosaclear SYSTEM metronidazole kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62032-507 Packaging # Item Code Package Description 1 NDC:62032-507-65 1 KIT in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 198 mL Part 2 1 TUBE 85 g Part 3 1 TUBE 45 g Part 1 of 3 Rosaclear SYSTEM GENTLE CLEANSER inert liquid Product Information Route of Administration TOPICAL DEA Schedule Ingredients Ingredient Name Quantity WATER GLYCERIN PHENOXYETHANOL METHYLPARABEN PROPYLPARABEN BUTYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN APRICOT KERNEL OIL SODIUM LAUROYL OAT AMINO ACIDS COCAMIDOPROPYL BETAINE SODIUM LAURETH SULFATE ALOE VERA LEAF GLYCERETH-7 PANTHENOL DIETHYLENE GLYCOL MONOETHYL ETHER TROLAMINE SAGE FD&C YELLOW NO. 5 OLEYL LACTATE CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 198 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2009 Part 2 of 3 Rosaclear SYSTEM HYDRATING COMPLEXION CORRECTOR inert cream Product Information Route of Administration TOPICAL DEA Schedule Ingredients Ingredient Name Quantity ALOE VERA LEAF WATER SILICON DIOXIDE DIPROPYLENE GLYCOL POLYETHYLENE GLYCOL 300 POLYETHYLENE GLYCOL 400 TALC METHYLPARABEN ALUMINUM OXIDE PROPYLPARABEN ISOHEXADECANE MICA FERRIC OXIDE RED FERROSOFERRIC OXIDE .ALPHA.-TOCOPHEROL ACETATE GLYCERYL MONOSTEARATE PEG-100 STEARATE ETHYLPARABEN ISOBUTYLPARABEN BUTYLPARABEN PHENOXYETHANOL GLYCERIN FERRIC OXIDE YELLOW HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) TITANIUM DIOXIDE COCO-CAPRYLATE/CAPRATE ETHYLHEXYL PALMITATE PROPYLENE GLYCOL ARNICA MONTANA FLOWER CUPRESSUS SEMPERVIRENS SEED POLYGONATUM MULTIFLORUM ROOT SARCOSINE POTASSIUM ASPARTATE MAGNESIUM ASPARTATE POLYSORBATE 60 ISOCETYL BEHENATE STEARYL ALCOHOL C13-15 ALKANE DIMETHICONE LAVANDULA ANGUSTIFOLIA FLOWERING TOP ALLANTOIN CETYL ALCOHOL OAT XANTHAN GUM LEVOMENOL MAGNESIUM ALUMINUM SILICATE PENTYLENE GLYCOL PSEUDOPTEROGORGIA ELISABETHAE GLYCYRRHIZA GLABRA Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2009 Part 3 of 3 METRONIDAZOLE metronidazole gel Product Information Item Code (Source) NDC:62032-123 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METRONIDAZOLE (METRONIDAZOLE) METRONIDAZOLE 7.5 mg in 1 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM METHYLPARABEN PROPYLPARABEN PROPYLENE GLYCOL WATER SODIUM HYDROXIDE CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) Packaging # Item Code Package Description 1 NDC:62032-123-65 45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077547 12/29/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/29/2012 Labeler - OMP, INC. (790553353) Establishment Name Address ID/FEI Operations TOLMAR PHARMACEUTICALS 791156578 MANUFACTURE(62032-507) Establishment Name Address ID/FEI Operations Swiss-American Products 611921669 MANUFACTURE(62032-507) Revised: 03/2013 OMP, INC. Next Interactions Print this page Add to My Med List More about Rosaclear (metronidazole topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: topical anti-rosacea agents Consumer resources Professional resources Metronidazole topical (AHFS Monograph) Metronidazole Vaginal Gel (FDA) Other brands: MetroGel , MetroGel-Vaginal , MetroCream , Noritate , ... +5 more Related treatment guides Rosacea} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Drug Class Topical anti-rosacea agents Related Drugs topical anti-rosacea agents metronidazole topical , brimonidine topical , MetroGel , Finacea , oxymetazoline topical , MetroGel-Vaginal Rosacea doxycycline , metronidazole topical , brimonidine topical , Lotemax , MetroGel , Vibramycin , ivermectin topical , Finacea , Monodox , oxymetazoline topical , Alrex , Soolantra , Oracea , MetroCream , Mirvaso , Doryx , Noritate , azelaic acid topical , Azelex , Vibra-Tabs , Rhofade , MetroLotion , Sumadan , More... 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