Obagi C Rx System C Clarifying Serum
Hydroquinone
Obagi Cosmeceuticals Llc
Human Prescription Drug
NDC 62032-106Obagi C Rx System C Clarifying Serum also known as Hydroquinone is a human prescription drug labeled by 'Obagi Cosmeceuticals Llc'. National Drug Code (NDC) number for Obagi C Rx System C Clarifying Serum is 62032-106. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Obagi C Rx System C Clarifying Serum drug includes Hydroquinone - 40 mg/mL . The currest status of Obagi C Rx System C Clarifying Serum drug is Active.
Drug Information:
| Drug NDC: | 62032-106 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Obagi C Rx System C Clarifying Serum |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Hydroquinone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Obagi Cosmeceuticals Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYDROQUINONE - 40 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Jan, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Obagi Cosmeceuticals LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0362032106106
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175851
N0000175854
N0000175850
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | XV74C1N1AE
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Melanin Synthesis Inhibitors [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Melanin Synthesis Inhibitor [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Depigmenting Activity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Depigmenting Activity [PE]
Melanin Synthesis Inhibitor [EPC]
Melanin Synthesis Inhibitors [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 62032-106-10 | 1 BOTTLE, GLASS in 1 CARTON (62032-106-10) / 30 mL in 1 BOTTLE, GLASS | 01 Jan, 2010 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Obagi c rx system c clarifying serum hydroquinone hydroquinone hydroquinone ascorbic acid propylene carbonate propylene glycol sodium lauryl sulfate water
Indications and Usage:
Indications and usage the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
Warnings:
Warnings ⢠hydroquinone is a skin-bleaching agent, which may produce unwanted cosmetic effects if not used as directed. the physician should be familiar with the contents of this insert before prescribing or dispensing this product. ⢠test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check within 24 hours. minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, the product should be discontinued and a physician consulted. close patient supervision is recommended. ⢠avoid contact with eyes, nose, mouth, and lips. in case of accidental contact, the patient should rinse thoroughly with water and contact a physician. ⢠sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. the obagi-c ® rx system c-therapy night cream contains sodium metabisulfite, a sulfite that may cause all
Read more...ergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. the overall prevalence of sulfite sensitivity in the general population is unknown and probably low. sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Dosage and Administration:
Dosage and administration a thin application should be applied once or twice daily or as directed by a physician. if no improvement is seen after three (3) months of treatment, use of this product should be discontinued. sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
Contraindications:
Contraindications people with prior history of sensitivity or allergic reaction to this product or any of its ingredients should not use it. the safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.
Adverse Reactions:
Adverse reactions no systemic adverse reactions have been reported. occasional hypersensitivity (localized contact dermatitis) may occur, in which case the product should be discontinued and physician notified immediately. to report suspected adverse reactions, contact obagi medical products, a division of valeant pharmaceuticals north america llc, at 1-800-321-4576 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Use in Pregnancy:
Pregnancy pregnancy category c animal reproduction studies have not been conducted with topical hydroquinone. it is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. it is not known to what degree, if any, topical hydroquinone is absorbed systemically. topical hydroquinone should be used on pregnant women only when clearly indicated.
Pediatric Use:
Pediatric usage safety and effectiveness in children, below the age of 12 years, have not been established.
Description:
Description hydroquinone is 1,4-benzenediol. hydroquinone occurs as fine, white needles. the drug is freely soluble in water and in alcohol. chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is c6h6o2; molecular weight is 110.11 g per mol. the chemical structure is in the diagram. chemstructure
Clinical Pharmacology:
Clinical pharmacology topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (dopa) and suppression of other melanocyte metabolic processes. exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas, which may be prevented by the use of sunscreen agents contained in the obagi-c® rx system sun shield matte broad spectrum spf 50.
How Supplied:
How supplied obagi-c ® rx system c-clarifying serum (hydroquinone, usp 4%) for normal to dry skin is available as follows: 1 fl. oz. (30 ml) bottle ndc 62032-106-10 obagi-c ® rx system c-clarifying serum (hydroquinone, usp 4%) for normal to oily skin is available as follows: 1 fl. oz. (30 ml) bottle ndc 62032-122-10 obagi-c ® rx system c-therapy night cream (hydroquinone, usp 4%) is available as follows: net wt. 2 oz. (57 g) bottle ndc 62032-105-36 store at controlled room temperature: 15° to 25°c (59° to 77°f). keep out of direct sunlight.
Information for Patients:
Patient information for topical use only complete skin care regimen formulated with 4% hydroquinone to reduce hyperpigmentation and other essential ingredients to help address the signs of skin aging caused by photoaging. please read this product information prior to use of the obagi-c® rx system. any questions regarding your particular skin care regimen should be directed to your physician. more information about the obagi-c® rx system or other obagi systems is available at our website at www.obagi.com.
Package Label Principal Display Panel:
Principal display panel - 30 ml bottle carton obagi-c ® rx system ndc# 62032-106-10 c-clarifying serum skin lightening serum with vitamin c 10% hydroquinone usp, 4% rx only for normal to dry skin am 1fl. oz. (30 ml) principal display panel - 30 ml bottle carton