HYDROQUINONE, OCTINOXATE, and OXYBENZONE

FDA Drug Profile — NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE

Drug Details

Generic Name
HYDROQUINONE, OCTINOXATE, and OXYBENZONE
Brand Names
NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE
Application Number
Sponsor
Obagi Cosmeceuticals LLC
NDC Codes
1
Dosage Forms
LOTION
Routes
TOPICAL
Active Ingredients
HYDROQUINONE, OCTINOXATE, OXYBENZONE

Indications and 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.

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. 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 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 .