- SPL UNCLASSIFIED SECTION
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PATIENT MEDICATION INFORMATION
For topical use only
Help correct early signs of aging and skin damage before they become a problem! This early
intervention system helps keep your skin protected and proactively addresses emerging signs of
skin 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 - strength
hydroquinone and the power of Vitamin - C.
Please read this product infomration 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.
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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 sulfate
Each 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, fragrance
Each 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, ascorbic
acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT
- DESCRIPTION
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CLINICAL PHARMACOLOGY
Topical application of hydroquinone produces a reversible depigmentation of the skin by
inhibition of the enzymatic oxidation of 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
sunblocking agents or sunscreen agents contained in the Obagi - C Rx System sun Shield Matte
Broad Spectrum SPF 50.
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
A thin application should be applied once or twice daily or as directed by a physician. no
improvement is seen after three (3) months of treatment, use of this product should be
discontinued. 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 to
prevent darkening from reoccuring.
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WARNINGS
Hydroquinoone 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, 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 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 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 populationis unknown and probably low. Sulfite sensitivity is seen
more frequently in asthmatic than in nonasthmatic people.
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PRECAUTIONS
(also 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 Category C
Animal reproduction studies have not been conducted with topical hydroquinone. It is also
not known whether hydroquinone can case 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
- CONTRAINDICATIONS
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OBAGI - C
hydroquinone liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69269-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ASCORBIC ACID (UNII: PQ6CK8PD0R) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69269-106-10 1 in 1 CARTON 1 30 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/2014 Labeler - YS PLUS CORPORATION (843007597) Establishment Name Address ID/FEI Business Operations YS PLUS CORPORATION 843007597 repack(69269-106)