ROSACLEAR SYSTEM- metronidazole kit

ROSACLEAR SYSTEM by

Drug Labeling and Warnings

ROSACLEAR SYSTEM by is a Prescription medication manufactured, distributed, or labeled by OMP, INC., TOLMAR PHARMACEUTICALS, Swiss-American Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ROSACLEAR SYSTEM 
metronidazole kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62032-507

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-507-65	1 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 
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	BUTYLPARABEN (UNII: 3QPI1U3FV8)
INGR	ETHYLPARABEN (UNII: 14255EXE39)
INGR	ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
INGR	APRICOT KERNEL OIL (UNII: 54JB35T06A)
INGR	SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	GLYCERETH-7 (UNII: 3D2Y91QZ2H)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	SAGE (UNII: 065C5D077J)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	OLEYL LACTATE (UNII: B3AWW0N3GM)
INGR	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 
face and neck (excluding shaving preparations) cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	WATER (UNII: 059QF0KO0R)
INGR	SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
INGR	POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
INGR	TALC (UNII: 7SEV7J4R1U)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	ALUMINUM OXIDE (UNII: LMI26O6933)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	ISOHEXADECANE (UNII: 918X1OUF1E)
INGR	MICA (UNII: V8A1AW0880)
INGR	FERRIC OXIDE RED (UNII: 1K09F3G675)
INGR	FERROSOFERRIC OXIDE (UNII: XM0M87F357)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	ETHYLPARABEN (UNII: 14255EXE39)
INGR	ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
INGR	BUTYLPARABEN (UNII: 3QPI1U3FV8)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
INGR	HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
INGR	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
INGR	COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
INGR	ETHYLHEXYL PALMITATE (UNII: 2865993309)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INGR	CUPRESSUS SEMPERVIRENS SEED (UNII: V5M93EG3SN)
INGR	POLYGONATUM MULTIFLORUM ROOT (UNII: EYW899536C)
INGR	SARCOSINE (UNII: Z711V88R5F)
INGR	POTASSIUM ASPARTATE (UNII: OC4598NZEQ)
INGR	MAGNESIUM ASPARTATE (UNII: R17X820ROL)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	ISOCETYL BEHENATE (UNII: JGD5498E0G)
INGR	STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
INGR	C13-15 ALKANE (UNII: 114P5I43UJ)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	OAT (UNII: Z6J799EAJK)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
INGR	GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)	METRONIDAZOLE	7.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
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	Business Operations
TOLMAR PHARMACEUTICALS		791156578	MANUFACTURE(62032-507)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American Products		611921669	MANUFACTURE(62032-507)