NDC 62032-122 Obagi-c Rx System C-clarifying Serum Normal To Oily Skin Lightening Serum With Vitamin C

Hydroquinone

NDC Product Code 62032-122

NDC CODE: 62032-122

Proprietary Name: Obagi-c Rx System C-clarifying Serum Normal To Oily Skin Lightening Serum With Vitamin C What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydroquinone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Hydroquinone is used to lighten the dark patches of skin (also called hyperpigmentation, melasma, "liver spots," "age spots," freckles) caused by pregnancy, birth control pills, hormone medicine, or injury to the skin. This medicine works by blocking the process in the skin that leads to discoloration.

NDC Code Structure

  • 62032 - Obagi Cosmeceuticals Llc
    • 62032-122 - Obagi-c Rx System C-clarifying Serum Normal To Oily

NDC 62032-122-10

Package Description: 1 BOTTLE, GLASS in 1 CARTON > 30 mL in 1 BOTTLE, GLASS

NDC Product Information

Obagi-c Rx System C-clarifying Serum Normal To Oily Skin Lightening Serum With Vitamin C with NDC 62032-122 is a a human prescription drug product labeled by Obagi Cosmeceuticals Llc. The generic name of Obagi-c Rx System C-clarifying Serum Normal To Oily Skin Lightening Serum With Vitamin C is hydroquinone. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Obagi Cosmeceuticals Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Obagi-c Rx System C-clarifying Serum Normal To Oily Skin Lightening Serum With Vitamin C Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYDROQUINONE 40 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALCOHOL (UNII: 3K9958V90M)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Melanin Synthesis Inhibitor - [EPC] (Established Pharmacologic Class)
  • Melanin Synthesis Inhibitors - [MoA] (Mechanism of Action)
  • Depigmenting Activity - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Obagi Cosmeceuticals Llc
Labeler Code: 62032
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 01-01-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Obagi-c Rx System C-clarifying Serum Normal To Oily Skin Lightening Serum With Vitamin C Product Label Images

Obagi-c Rx System C-clarifying Serum Normal To Oily Skin Lightening Serum With Vitamin C Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

WELCOME TO THE OBAGI-C® RX SYSTEM OF SKIN CARE PRODUCTS!

Distributed by:Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USAU.S. Patent 6,299,889Obagi-C is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.©OMP, Inc.www.obagi.com 9578900Revised: 10/2016

Patient Information

For Topical Use OnlyComplete 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.

Physician Prescribing Information

Rx onlyFOR EXTERNAL USE ONLY

62032-106-10 Obagi-C® Rx System C-Clarifying Serum For Normal To Dry Skin

Each gram of Obagi-C® Rx System C-Clarifying Serum for Normal to Dry Skin contains:Active: Hydroquinone, USP 4% (40 mg per g)Inactives: ascorbic acid, propylene carbonate, propylene glycol, sodium lauryl sulfate, water

62032-122-10 Obagi-C® Rx System C-Clarifying Serum For Normal To Oily Skin

Each gram of Obagi-C® Rx System C-Clarifying Serum for Normal to Oily Skin contains:Active: Hydroquinone, USP 4% (40 mg per g)Inactives: ascorbic acid, dipropylene glycol, fragrance, propylene carbonate, propylene glycol, SD alcohol-39-C, sodium lauryl sulfate, water

62032-105-36 Obagi-C® Rx System C-Therapy Night Cream

Each gram of Obagi-C® Rx System C-Therapy Night Cream contains:Active: Hydroquinone, USP 4% (40 mg per g)Inactives: ascorbic acid, BHT, cetyl alcohol, disodium EDTA, glycerin, lactic acid, methylparaben, phenyl trimethicone, PPG-2 myristyl ether propionate, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, TEA-salicylate, tocopheryl acetate, water

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.

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.

Indications And Usage

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

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.

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 allergic-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.

Precautions

(See WARNINGS.)Treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation, which does not preclude treatment.

Pregnancy

Pregnancy Category CAnimal 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.

Nursing Mothers

It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.

Pediatric Usage

Safety and effectiveness in children, below the age of 12 years, have not been established.

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.

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.

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 62032-106-10Obagi-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 62032-122-10Obagi-C® Rx System C-Therapy Night Cream(Hydroquinone, USP 4%) is available as follows: Net wt. 2 oz. (57 g) bottle    NDC 62032-105-36Store at controlled room temperature: 15° to 25°C (59° to 77°F). Keep out of direct sunlight.

* Please review the disclaimer below.