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Rosaclear

Generic Name: metronidazole
Dosage Form: topical gel

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

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.



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