Obagi Nu-derm Recall
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Questions & Answers
Side Effects & Adverse Reactions
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
activity.
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
nonasthmatic people
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma,
freckles, senile pentigines, and other unwanted areas of melanin hyperpigmentation
History
There is currently no drug history available for this drug.
Other Information
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.
5.5 %
Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol,
tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, BHT, saponins, propylparaben, butylparaben
Sources