Websitewww.obagi.com
www.obagi.com
www.obagi.comROSACLEAR SYSTEM
- Manufacturer
- OMP, INC. | TOLMAR PHARMACEUTICALS | Swiss-American Products
- Effective date
- 2013-03-07
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:16:37
Label at a glance#
ProductROSACLEAR SYSTEM
Active ingredientMETRONIDAZOLE
Label structure11 sections
Contacts and useful links#
Label contents#
Full prescribing information#
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 SECTION
STORAGE AND HANDLING SECTION
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 SECTION
STORAGE AND HANDLING SECTION
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
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| METRONIDAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55 | Product name | 5 | 20251024 |
| 7f6d14e0-4366-41bc-a4a9-b74c79a20e17 | Product name | 1 | 20250623 |
| e6d321b0-0e5e-7da6-f043-92b6a91f00a1 | Product name | 5 | 20250515 |
| e1aac33b-94ae-4ee9-905b-299f7263853b | Product name | 3 | 20250124 |
| 16642716-d28a-4f90-8dcb-3921cd8c8109 | Product name | 4 | 20240516 |
| 0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15 | Product name | 1 | 20240313 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| a5070875-62bb-61e1-fd46-8f7054197a40 | Product name | 8 | 20180215 |
| 0add4de9-d152-3375-3390-1123dddc5e3d | Product name | 1 | 20140508 |
| 33ca0fcc-1011-92dc-50a9-a383683eed1e | Product name | 1 | 20140508 |
| 53f39d9f-cd3f-04e1-c668-d4580719d57d | Product name | 1 | 20140508 |
| a804000f-b74f-0b5d-d17b-aa767c286ddb | Product name | 1 | 20140508 |
| a91ea265-6e02-c08f-93c8-686d54180529 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62032-507-65 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e4b3-f424-e053-dadaa90a57ce | ROSACLEAR ® SYSTEM |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62032-123-65 | ROSACLEAR SYSTEM | 45 g in 1 TUBE | gel | 45 g | 7.5 mg in 1g | 1 |
| 62032-507-65 | ROSACLEAR SYSTEM | 1 in 1 CARTON | KIT | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 62032-123 | ROSACLEAR SYSTEM (METRONIDAZOLE) KIT [OMP, INC.] | 1 | Unmatched | 20130314_c52eeafb-1c8d-4f9c-a505-d7a3ee1ef94b.zip |
| 62032-507 | ROSACLEAR SYSTEM (METRONIDAZOLE) KIT [OMP, INC.] | 1 | Legacy NDC, 2 package rows | 20130314_c52eeafb-1c8d-4f9c-a505-d7a3ee1ef94b.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| METRONIDAZOLE | ACTIVE INGREDIENT | 140QMO216E | 1 | |
| METRONIDAZOLE | ACTIVE MOIETY | 140QMO216E | 1 | |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- ROSACLEAR SYSTEM
- METRONIDAZOLE
- ROSACLEAR SYSTEM GENTLE CLEANSER
- inert
- 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)
- ROSACLEAR SYSTEM HYDRATING COMPLEXION CORRECTOR
- SILICON DIOXIDE
- DIPROPYLENE GLYCOL
- POLYETHYLENE GLYCOL 300
- POLYETHYLENE GLYCOL 400
- TALC
- ALUMINUM OXIDE
- ISOHEXADECANE
- MICA
- FERRIC OXIDE RED
- FERROSOFERRIC OXIDE
- .ALPHA.-TOCOPHEROL ACETATE
- GLYCERYL MONOSTEARATE
- PEG-100 STEARATE
- FERRIC OXIDE YELLOW
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62032-507 | 62032-507-65 |
| 62032-123 | 62032-123-65 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PARENTERAL | 18 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET / ORAL | 0.2 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SUSPENSION / ORAL | 8 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRA-ARTICULAR | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAMUSCULAR | 95 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRALESIONAL | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / TOPICAL | 5148 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / TOPICAL | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | EMULSION / TOPICAL | 0.2 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, EXTENDED RELEASE / ORAL | 0.12 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / RECTAL | 97 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / TOPICAL | 29 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / ORAL | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRADERMAL | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / RECTAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RECTAL | 0.02 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBMUCOSAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTABLE, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | OINTMENT / TOPICAL | 1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / RECTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SUBCUTANEOUS | 2 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRATHECAL | 176 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAOCULAR | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAMUSCULAR | 4000 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / NASAL | 0.2 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PERIDURAL | ADJ PH | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / INTRAMUSCULAR | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, COATED / ORAL | 0.8 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INFILTRATION | 0.35 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / TOPICAL | 0.11 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / OPHTHALMIC | 0.05 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / RECTAL | 2 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CONCENTRATE / ORAL | 20 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / ORAL | 64 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / AURICULAR (OTIC) | 0.05 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBCONJUNCTIVAL | ADJ PH | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / TRANSDERMAL | 150 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4d112f06-a318-47da-8e30-0ca7d2d03583 | c52eeafb-1c8d-4f9c-a505-d7a3ee1ef94b | 2013-03-07 | 4d112f06-a318-47da-8e30-0ca7d2d03583 c52eeafb-1c8d-4f9c-a505-d7a3ee1ef94b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.