Label: ROSACLEAR SYSTEM- metronidazole kit

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated March 7, 2013

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  • 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.

  • 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

  • SPL UNCLASSIFIED SECTION

    FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE).
    RX ONLY.

  • HOW SUPPLIED

    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)

  • HOW SUPPLIED

    Store at controlled room temperature: 20°C–25°C (68°F–77°F). Do not freeze.

  • SPL UNCLASSIFIED SECTION

    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

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    ROSACLEAR SYSTEM 
    metronidazole kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62032-507
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-507-651 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 198 mL
    Part 21 TUBE 85 g
    Part 31 TUBE 45 g
    Part 1 of 3
    ROSACLEAR SYSTEM GENTLE CLEANSER 
    cleansing (cold creams, cleansing lotions, liquids, and pads) liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
    INGRETHYLPARABEN (UNII: 14255EXE39)  
    INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    INGRAPRICOT KERNEL OIL (UNII: 54JB35T06A)  
    INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRSODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRGLYCERETH-7 (UNII: 3D2Y91QZ2H)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGRSAGE (UNII: 065C5D077J)  
    INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    INGROLEYL LACTATE (UNII: B3AWW0N3GM)  
    INGRCARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1198 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/01/2009
    Part 2 of 3
    ROSACLEAR SYSTEM HYDRATING COMPLEXION CORRECTOR 
    face and neck (excluding shaving preparations) cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRPOLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    INGRPOLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    INGRTALC (UNII: 7SEV7J4R1U)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRALUMINUM OXIDE (UNII: LMI26O6933)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRISOHEXADECANE (UNII: 918X1OUF1E)  
    INGRMICA (UNII: V8A1AW0880)  
    INGRFERRIC OXIDE RED (UNII: 1K09F3G675)  
    INGRFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRETHYLPARABEN (UNII: 14255EXE39)  
    INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    INGRHYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    INGRTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    INGRCOCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
    INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGRARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INGRCUPRESSUS SEMPERVIRENS SEED (UNII: V5M93EG3SN)  
    INGRPOLYGONATUM MULTIFLORUM ROOT (UNII: EYW899536C)  
    INGRSARCOSINE (UNII: Z711V88R5F)  
    INGRPOTASSIUM ASPARTATE (UNII: OC4598NZEQ)  
    INGRMAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
    INGRISOCETYL BEHENATE (UNII: JGD5498E0G)  
    INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    INGRC13-15 ALKANE (UNII: 114P5I43UJ)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRLAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGROAT (UNII: Z6J799EAJK)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRLEVOMENOL (UNII: 24WE03BX2T)  
    INGRMAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRPSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    INGRGLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    185 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/01/2009
    Part 3 of 3
    METRONIDAZOLE 
    metronidazole gel
    Product Information
    Item Code (Source)NDC:62032-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E) METRONIDAZOLE7.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-123-6545 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07754712/29/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other12/29/2012
    Labeler - OMP, INC. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    TOLMAR PHARMACEUTICALS791156578MANUFACTURE(62032-507)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American Products611921669MANUFACTURE(62032-507)