ideas Alphaquin HP Cream Generic Name: hydroquinone, octinoxate, and oxybenzone Dosage Form: cream Overview Side Effects Dosage Professional Pregnancy More User Reviews Support Group Q & A Pricing & Coupons 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. ALPHAQUIN HP 4% CREAM Rx (HYDROQUINONE 4% USP SKIN BLEACHING MOISTURIZING TOPICAL CREAM WITH SUNSCREENS) Rx only FOR EXTERNAL USE ONLY: NOT FOR OPHTHALMIC, NASAL OR OTIC USE. Slideshow Treatment of Opioid-Induced Constipation: The Hard Facts Alphaquin HP Cream Description Each gram of ALPHAQUIN HP 4% CREAM Contains: ACTIVE: 40 mg of Hydroquinone USP, 7.5% Octyl Methoxycinnamate,5.0% Benzophenone-3 in a cream base of: INACTIVES: Purified Water, Propylene Glycol, Glycerine, Cetyl Alcohol, Cetostearyl Alcohol, Glycolic Acid, Isopropyl Palmitate, Stearyl Alcohol, Sodium Lauryl Sulfate, Sodium Metabisulfite, Citric Acid, Sorbic Acid and Sodium Hydroxide. Hydroquinone is 1, 4-Benzenediol, with a chemical formula of C6H6O2 and a molecular weight of 110.11. The structural formula is: Alphaquin HP Cream - Clinical Pharmacology Topical application of hydroquinone produces a reversible depigmentation of the skin by the inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA) [Denton, C., et al., 1952 (1)] and suppression of other melanocyte metabolic processes [Jimbow, K., et al., 1974 (2)]. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas [Parrish, J.A. et al., 1978 (3)]. Indications and Usage for Alphaquin HP Cream ALPHAQUIN HP 4% CREAM is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other undesired areas of melanin hyperpigmentation. Contraindications ALPHAQUIN HP 4% CREAM is contraindicated in persons who have shown hypersensitivity to hydroquinone or any of the other ingredients. The safety of topical treatment of hydroquinone during pregnancy or in children (12 years and under) has not been established. (See PRECAUTIONS ). Warnings Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication. To evaluate possible susceptibility to irritation or sensitivity, each patient should begin by applying the medication to a small portion of unbroken skin at or near the pigmented area over a period of several days. Minor redness is not necessarily a contraindication, but treatment should be discontinued if itching, excessive inflammation or vesicle formation occurs. Close patient supervision is recommended. Use of ALPHAQUIN HP 4% CREAM in paranasal and infraorbital areas increases the chance of irritations (See ADVERSE REACTIONS ). If no improvement is seen after two months of treatment, use of this product should be discontinued. Sunscreen use is an essential aspect of hydroquinone therapy since even minimal sunlight exposure stimulates melanocyte activity. The sunscreens in ALPHAQUIN HP 4% CREAM provide the necessary sun protection during skin bleaching activity. During the depigmentation maintenance treatment subsequent to the intensive depigmentation therapy, sun exposure of the bleached skin should be avoided to prevent repigmentation. 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. Keep this and all other medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately. Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. A bitter taste and antiseptic effect may occur if applied to the lips. Precautions (SEE WARNINGS ) Pregnancy Category C Animal reproduction studies have not been conducted with hydroquinone. It is also not known whether hydroquinone can cause fetal harm when administered on a pregnant woman or can affect reproductive capacity. It is also not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used in pregnant women only when clearly indicated. Nursing Mothers It is not known whether topical administration of hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother. Pediatric Use Safety and effectiveness in children below the age of 12 years has not been established. Adverse Reactions No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately. Overdosage There have been no systemic reactions reported from the use of topical hydroquinone treatment. However, treatment should be limited to relatively small areas of the body at one time since some patients may experience a transient skin reddening and a mild burning sensation which does not preclude treatment. Alphaquin HP Cream Dosage and Administration ALPHAQUIN HP 4% CREAM should be applied to affected areas twice daily, in the morning and before bedtime, or as directed by a physician. Unnecessary solar exposure should be avoided. There is no recommended dosage for children under 12 years of age except under the advice and supervision of a physician. Keep container tightly closed. NOTE: Slight darkening of ALPHAQUIN HP 4% CREAM is normal and does not affect potency of the product. How is Alphaquin HP Cream Supplied ALPHAQUIN HP 4% CREAM (Hydroquinone, USP 4%) is supplied as follows: SIZE NDC NUMBER 1 oz tube (28.4 grams) 58980-580-10 2 oz tube (56.7 grams) 58980-580-20 STORAGE Store at 20 C to 25 C (68 F to 77 F), excursions permitted between 15 C and 30 C (between 59 F and 86 F). Brief exposure to temperatures up to 40 C (104 F) may be tolerated provided the mean kinectic temperature does not exceed 25 C (77 F); however, such exposure should be minimized. [See USP Controlled Room Temperature]. Protect from freezing. If freezing occurs, warm to room temperature. Keep out of the reach of children. Distributed by: STRATUS STRATUS PHARMACEUTICALS INC 12379 SW 130TH STREET MIAMI, FLORIDA 33186 Manufactured by: Sonar Products, Inc. Carlstadt, NJ 07072 Copyright 1993, Stratus Pharmaceuticals, Inc. All rights reserved. HYDROQUINONE REFERENCES Denton, C., Lerner, A., and Fitzpatrick, T., "Inhibition of Melanin Formation by Chemical Agents", J. Invest. Derm. , 18:119-135, 1952. Jimbow, K., Obata, M., Pathak, M., and Fitzpatrick, T., "Mechanisms of Depigmentation by Hydroquinone" J. Invest. Derm. , 62:436-449, 1974. Parrish, J, Anderson, R., Urbach, F., and Pitts, D., " Biological Effects of Ultraviolet Radiation with Emphasis on Human Responses to Longwave Ultraviolet", Plenum Press, New York, 1978 (page 151). Rev. JG-ACI 2012-304 PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton NDC 58980-580-10 Net WT. 1 OZ (28.4g) ALPHAQUIN HP 4% CREAM STRATUS PHARMACEUTICALS INC (HYDROQUINONE USP, 4%) SKIN BLEACHING CREAM WITH SUNSCREENS Rx only Distributed by Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186 ALPHAQUIN HP hydroquinone, octinoxate, and oxybenzone cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-580 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydroquinone (Hydroquinone) Hydroquinone 40 mg in 1 g Octinoxate (Octinoxate) Octinoxate 75 mg in 1 g Oxybenzone (Oxybenzone) Oxybenzone 50 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:58980-580-20 1 TUBE in 1 BOX 1 56.7 g in 1 TUBE 2 NDC:58980-580-10 1 TUBE in 1 BOX 2 28.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1993 Labeler - Stratus Pharamceuticals (789001641) Establishment Name Address ID/FEI Operations Sonar Products Inc 104283945 MANUFACTURE(58980-580) Revised: 11/2012 Stratus Pharamceuticals Next Pregnancy Warnings Print this page Add to My Med List More about hydroquinone topical Side Effects During Pregnancy Dosage Information Support Group Pricing & Coupons 5 Reviews Add your own review/rating Drug class: topical depigmenting agents Consumer resources Hydroquinone topical Hydroquinone Hydroquinone with Sunscreen Cream and Gel Professional resources Hydroquinone (AHFS Monograph) Hydroquinone Cream (FDA) Hydroquinone Cream with Sunscreens (FDA) Hydroquinone Time Release Cream (FDA) Hydroquinone (Wolters Kluwer) Other brands: Melamin , Lustra , Melquin HP , Melpaque HP , ... +19 more Related treatment guides Dermatological Disorders} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Manufacturers Perrigo Company Acella Pharmaceuticals, LLC Drug Class Topical depigmenting agents Related Drugs topical depigmenting agents hydroquinone topical , Melamin , Tri-Luma , Lustra Dermatological Disorders triamcinolone , clobetasol topical , betamethasone , Temovate , Diprolene , Analpram-HC , Celestone , urea topical , Clobex , Valisone , Proctofoam HC , hydroquinone topical , sodium hyaluronate topical , Olux , Betamethacot , Diprosone , salicylic acid topical , Diprolene AF , Melamin , Celestone Soluspan , Analpram E , Clobevate , More... Hydroquinone topical Rating 5 User Reviews 2.8 /10 5 User Reviews 2.8 Rate it!} } outcome
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