OBAGI NU-DERM — hydroquinone cream
YS PLUS CORPORATION
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
For external use only
Hydroquinone is 1,4 benzenediol. The drug is freely soluble in water and in alcohol.
Chemically, hydroquinone is designed as p — dihydroxybenzene; the empirical formula is C6H6)2;
molecular weight is 110.11 g / moL.
Each gram of Obagi Nu — Derm contains:
Active ingredient: Hydroquinone USP, 4 % (40 mg / g)
Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic
acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium ESTA, methylparaben, BHT,
propylparaben, saponins, butylparaben
Each gram of Obagi Nu 0 Derm Blender contains:
Active ingredient: Hydroquinone USP 4 % (40 mg / g)
Inactive ingredients: water, glycerin, cetyl alcohol, PPG — 2 myristal ether propionate, sodium
lauryl sulfate, TEA — salicylate, lactic acid, phenyl trimethicone, tocopherylcetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA,
propylparaben, saponins, BHT
Each gram of Obagi Nu — Derm Sunfader contains:
Active ingredients: Hydroquinone USP 4 % (40 ,g /g/); Octinoxate USP, 7.5 %; Oxybenzene USP.
Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol,
tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, BHT, saponins, propylparaben, butylparaben
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 ultraiolet light
will cause repigmentation of the bleached areas, which may be orevented by the use of
sunblocking agents or sunscreen agents contained in the Obagi Nu — Derm Sunfader and Obagi
Nu — Derm Sun shield Matte Broad Spectrum SPF 50.
For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma,
freckles, senile pentigines, and other unwanted areas of melanin hyperpigmentation
People with prior history of sensitivity or allergic reaction to this product or any of its
ingredients should not use it. The safety of hydroquinone use during pregnancy or in
children (12 years and under) has not been established.
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, product should be discontinued and
physician consulted. Close patient supervision is recommended.
Warnings: 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
Contains sodium metabusulfite, a sulfite that may cause allergic — type reactions including
anaphylactic symptoms and life — threatening or elss severe asthmatic episodes in
certain susceptible people. The overall prevalence of sulfite sensitivity in te general population is
unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in
(See also 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 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
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.
Safety and effectiveness in children below the age of 12 years have not been established.
No systemic adverse reactions ahve been reported. Occasional hypersensitivity
(localized contact dermatitis) may occur, in which case the product should be
discontinues and the physician notified immediately.
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, a sunblocking agent or protective clothing to cover bleached skin when using and after using this
product in order to prevent darkening from reoccurring.
Store at controlled room temperature: 15 C — 25 C (59 F — 77 F). Keep out of direct sunlight.
|OBAGI NU-DERM hydroquinone cream|
|Labeler — YS PLUS CORPORATION (843007597)|
|YS PLUS CORPORATION||843007597||repack (69269-100)|
Revised: 10/2014 YS PLUS CORPORATION
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