Obagi-C Rx system C-Therapy Night
Hydroquinone · Cream · Topical
Uses
The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
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
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.
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 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. 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.
Side effects
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.
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 C 6 H 6 O 2 ; molecular weight is 110.11 g per mol. The chemical structure is in the diagram. chemstructure
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.
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.
Label text from the FDA structured product label by Obagi Cosmeceuticals LLC (revised Jun 1, 2020). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Hydroquinone in 1 product
Obagi-C Rx system C-Therapy Night NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 62032-105 | Hydroquinone 40 mg/g Cream | Obagi Cosmeceuticals LLC | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Obagi-C Rx system C-Therapy Night used for?
The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
What are the side effects of Obagi-C Rx system C-Therapy Night?
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. See the full label for the complete list.
Who makes Obagi-C Rx system C-Therapy Night?
Obagi-C Rx system C-Therapy Night is listed by 1 labeler in the FDA NDC directory, including Obagi Cosmeceuticals LLC.