ROSACLEAR SYSTEM- metronidazole 
OMP, INC.

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.

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

PRINCIPAL DISPLAY PANEL - Kit Carton
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)

Revised: 3/2013
Document Id: 4d112f06-a318-47da-8e30-0ca7d2d03583
Set id: c52eeafb-1c8d-4f9c-a505-d7a3ee1ef94b
Version: 1
Effective Time: 20130307
 
OMP, INC.