{"effective_time":"20121108","id":"f3bc1d92-cd3c-4ed2-895d-4b9c2e3321fc","openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 28.4 g Tube Label NDC 58980-580-10 Net WT. 1 OZ (28.4g) ALPHAQUIN ® HP 4% CREAM STRATUS PHARMACEUTICALS INC (HYDROQUINONE USP, 4%) Rx only SKIN BLEACHING CREAM WITH SUNSCREENS Distributed by Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186 DESCRIPTION: Each gram of ALPHAQUIN ® HP 4% CREAM contains ACTIVES: 4% Hydroquinone USP, 7.5% Octyl Methoxycinnamate, 5% Benzophenone-3 in a cream base of INACTIVES: Cetostearyl Alcohol, Cetyl Alcohol, Citric Acid, Glycerine, Glycolic Acid, Isopropyl Palmitate, Propylene Glycol, Purified Water, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sorbic Acid and Stearyl Alcohol. USUAL DOSAGE: Apply ALPHAQUIN® HP 4% CREAM to the affected areas twice daily or as directed by a physician. Rub into skin well. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC, NASAL OR OTIC USE. Keep this and all other medications out of reach of children. SEE PACKAGE INSERT FOR FULL INFORMATION. WARNING: 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. STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F). Protect from Freezing. [See USP Controlled Room Temperature.] Keep tightly closed. See crimp for lot number and expiration date. Manufactured by: Sonar Products, Inc., Carlstadt, NJ 07072 Rvd. AC-1-2012-304 PRINCIPAL DISPLAY PANEL - 28.4 g Tube Label"],"set_id":"caf1ee18-7cc9-4054-bc13-9e6d0c160fae","spl_product_data_elements":["Alphaquin HP Hydroquinone, Octinoxate, and Oxybenzone Hydroquinone Hydroquinone Octinoxate Octinoxate Oxybenzone Oxybenzone Water Propylene Glycol Glycerin Cetyl Alcohol Cetostearyl Alcohol Glycolic Acid Isopropyl Palmitate Stearyl Alcohol Sodium Lauryl Sulfate Sodium Metabisulfite Citric Acid Monohydrate Sorbic Acid Sodium Hydroxide"],"version":"1"}