NU-DERM system NORMAL-oily SKIN TRANSFORMATION TRIAL
Generic: HYDROQUINONE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE
Basic Information
Manufacturer
OBAGI COSMECEUTICAL LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
48a6f977-d7b8-4da4-8bab-b3b8df5347c3
Purpose
Active ingredients Purpose Homosalate 10% Sunscreen Octisalate 5% Sunscreen Zinc Oxide 16.5% Sunscreen
Indications & Usage
INDICATIONS AND USAGE For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.
Uses helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Uses helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
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.
Some users of this product may experience a mild skin irritation.
If skin irritation becomes severe, stop use and consult a doctor.
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 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.
Warnings For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes.
Rinse with water to remove.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
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.
Some users of this product may experience a mild skin irritation.
If skin irritation becomes severe, stop use and consult a doctor.
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 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.
Warnings For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes.
Rinse with water to remove.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Adverse Reactions
ADVERSE REACTIONS No systemic adverse reactions have been reported.
Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the product should be discontinued and the physician notified immediately.
To report SUSPECTED ADVERSE REACTIONS, contact Obagi Cosmeceuticals LLC, at 1-800-636-7546 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the product should be discontinued and the physician notified immediately.
To report SUSPECTED ADVERSE REACTIONS, contact Obagi Cosmeceuticals LLC, at 1-800-636-7546 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.