NDC 69269-106 Obagi - C

NDC Product Code 69269-106

NDC 69269-106-10

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Obagi - C with NDC 69269-106 is a product labeled by Ys Plus Corporation. The generic name of Obagi - C is . The product's dosage form is and is administered via form.

Labeler Name: Ys Plus Corporation

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.

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

Product Labeler Information

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

Labeler Name: Ys Plus Corporation
Labeler Code: 69269
Start Marketing Date: 10-01-2014 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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Obagi - C Product Label Images

Obagi - 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!For external use onlyRx only

Patient Medication Information

For topical use onlyHelp correct early signs of aging and skin damage before they become a problem! This earlyintervention system helps keep your skin protected and proactively addresses emerging signs ofskin dmaage to refresh and maintain youthful, healthy - looking skin. The Obagi - C Rx System is a unique skin care regumen that combines the benefits of both prescription - strengthhydroquinone and the power of Vitamin - C.Please read this product infomration prior to use of the Obagi - C Rx System. Any questionsregarding your particular skin care regimen should be directed to your physician. Moreinformation about the Obagi - C Rx System or other Obagi systems is available at our website atwww.obagi.com.

Information For Patients

Each gram of Obagi - C Rx System C - Clarifying Serum for Normal to Dry Skin contains:Active ingredient:Hydroquinone USP, 4 % (40 mg / g)Inactive Ingredients:propylene glycol, water, ascorbic acid, propylene carbonate, sodium lauryl sulfateEach gram of Obagi - C Rx System C - Clarifying Serum for Normal to Oily Skin contains:Active Ingredient:Hydroquinone USP, 4 % (40 mg / g)Inactive ingredients:water, propylene glycol, alcohol denat., dipropylene glycol, ascorbic acid, propylene carbonate,sodium lauryl sulfate, fragranceEach gram of Obagi - C Rx System C - Therapy Night Cream contains:Active ingredient:Hydroquinone USP, 4 % (40 mg / g)Inactive Ingredients:water, glycerin, cetyl alcohol, PPG - 2 myristyl ether propionate, sodium lauryl sulfate, TEA - salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbicacid, methylparaben, disodium EDTA, propylparaben, saponins, BHT

Description

Hydroquinone is 1,4 - bensenediol. Hydroquinone occurs as fine, white needles. The drug is freelysoluble in water and in alcohol. Chemically, hydroquinone is designated as p - dihydroxybenzene;the empirical formula is C6H6O2; molecular weight is 110.11 g / moL.

Clinical Pharmacology

Topical application of hydroquinone produces a reversible depigmentation of the skin byinhibition of the enzymatic oxidation of 3, 4 - dihydroxyphenylalanine (DOPA) andsuppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet lightwill cause repigmentation of the bleached areas, which may be prevented by the use ofsunblocking agents or sunscreen agents contained in the Obagi - C Rx System sun Shield MatteBroad Spectrum SPF 50.

Indications & Usage

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

Dosage & Administration

A thin application should be applied once or twice daily or as directed by a physician.  noimprovement is seen after three (3) months of treatment, use of this product should bediscontinued. Sun exposure may be limited by using a sunscreen agent, a sunblocking agent,or protective clothing to cover bleached skin when using and after using this product in order toprevent darkening from reoccuring.

Warnings

Hydroquinoone is a skin - bleaching agent, which may produce unwanted cosmetic effects if notused 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 skinand check within 24 hours. Minor redness is not a contraindication, but where there is itchingor vesicle formation or excessive inflammatory response, product should be discontinued and physician consulted. Close patient supervision is recommended.Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient shouldrinse 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 Therapy Night Cream contains sodium metabisulfite, a sulfite thatmay cause allergic - type reactions including anaphylactic symptoms and life - threatening orless severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfitesensitivity in the general populationis unknown and probably low. Sulfite sensitivity is seenmore frequently in asthmatic than in nonasthmatic people.

Precautions

(also see WARNINGS)Treatment should be limited to relatively small areas of the body at one time since somepatients experience a transient skin reddening and a mild burning sensation, which does notpreclude treatment.Pregnancy Category CAnimal reproduction studies have not been conducted with topical hydroquinone. It is alsonot known whether hydroquinone can case fetal harm when used topically on a pregnant womanor affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone isabsorbed systemically. Topical hydroquinone should be used on pregnant women only whenclearly indicated.Nursing MothersIt is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution isadvised when topical hydroquinone is used by a nursing mother.Pediatric UsageSafety 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 (localizedcontact dermatitis) may occur, in which case the product should be discontinued and physiciannotified immediately.

Contraindications

People with prior history of sensitivity or allergic reaction to this product or any of itsingredients should not use it. The safety of topical hydroquinone use during pregnancyor in children (12 years and under) has not been established.

Storage And Handling

Store at controlled room temperature 15 C - 25 C (59 F - 77 F). Keep out of direct sunlight

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