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Lustra-AF (Hydroquinone Octyl Methoxycinnamate Avobenzone)

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Pharmacology
 Skin discoloration is due to increased amounts of the skin pigment called melanin in certain skin areas (also called hyperpigmentation). It can be caused by sun exposure, increased age, the use of oral contraceptives or pregnancy. This usually develops gradually and increases dramatically with sun exposure. Lustra-AF has been formulated to treat skin discoloration, dryness, and roughness of your skin. It contains hydroquinone to slow the production of melanin and lighten dark areas; softens skin, moisturizes, and reduces the appearance of wrinkles. Lustra-AF also contains an advanced broad spectrum sunblock system to help insure the best possible therapeutic results by minimizing ultra violet induced hyperpigmentation and sun damage. Best results can be achieved and maintained by avoiding sun exposure during and after treatment. The regular use of a UVA/UVB sunblock of SPF15 or greater is recommended, as well as the use of protective clothing. Treatment of skin discolouration is a gradual process requiring an 8-to 12-week period of twice daily applications to reach the full therapeutic effect. If no improvement is seen after this time, consult your physician. Make-up can be applied over Lustra-AF. For external use only

Indications
 Skin Discoloration Is Due To Increased Amounts Of The Skin Pigment Called Melanin In Certain Skin Areas (also Called Hyperpigmentation). It Can Be Caused By Sun Exposure, Increased Age, The Use Of Oral Contraceptives Or Pregnancy. This Usually Develops Gradually And Increases Dramatically With Sun Exposure. Lustra-AF Has Been Formulated To Treat Skin Discoloration, Dryness, And Roughness Of Your Skin. It Contains Hydroquinone To Slow The Production Of Melanin And Lighten Dark Areas; Softens Skin, Moisturizes, And Reduces The Appearance Of Wrinkles. Lustra-AF Also Contains An Advanced Broad Spectrum Sunblock System To Help Insure The Best Possible Therapeutic Results By Minimizing Ultra Violet Induced Hyperpigmentation And Sun Damage. Best Results Can Be Achieved And Maintained By Avoiding Sun Exposure During And After Treatment. The Regular Use Of A UVA/UVB Sunblock Of SPF15 Or Greater Is Recommended, As Well As The Use Of Protective Clothing. Treatment Of Skin Discolouration Is A Gradual Process Requiring An 8-to 12-week Period Of Twice Daily Applications To Reach The Full Therapeutic Effect. If No Improvement Is Seen After This Time, Consult Your Physician. Make-up Can Be Applied Over Lustra-AF. For External Use Only

Contraindications
In any patient that has a prior history of hypersensitivity or allergic reaction to hydroquinone, or any of the other ingredients. The safety of topical hydroquinone use during pregnancy or on children (under 12 years of age) has not been established.

Safety Information / Warning
Hydroquinone is a depigmenting agent which can produce unwanted cosmetic effects if not used as directed. Before beginning treatment, first test Lustra-AF for irritation by applying to a small area of unbroken skin. If excessive irritation, rash, or other reactions do not occur within 24 hours, begin treatment. Minor redness is not a contraindication, but where there is itching, vesicle formation, or excessive inflammatory response, further treatment is not advised. Contact with the eyes should be avoided. If no lightening effect is noted after 8 weeks of treatment, use of Lustra-AF should be discontinued. Sunscreen use is an essential aspect of hydroquinone therapy, because even minimal sunlight sustains melanocytic activity. The sunscreens in Lustra-AF provide the necessary sun protection during therapy. During and after the use of Lustra-AF, sun exposure should be limited or sun protective clothing should be used to cover the treated areas to prevent repigmentation. Keep this and all medications out of the reach of children. In case of accidental ingestion, contact a physician or Poison Control Centre immediately. Contains sodium metabisulphite, a sulphite which may cause serious allergic reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons. On rare occasions, a gradual, blue-black darkening of the skin may occur. In such case, use of Lustra-AF should be discontinued and a physician consulted immediately.

Precautions
Animal reproduction studies have not been conducted with topical hydroquinone.

Pregnancy:  It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or can affect reproductive capacity. It is not known to what degree, if any, hydroquinone is absorbed systemically. Topical hydroquinone should be used in pregnant women only where clearly indicated.

Lactation:  It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when hydroquinone is used by a nursing mother.

Children: Safety and effectiveness in pediatric patients below the age of 12 have not been established.

Side Effects / Adverse Effects
No systemic reactions have been reported. Occasional cutaneous hypersensitivity (localized contact dermatitis) may occur, in which case the medication should be discontinued. There have been no systemic reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and mild burning sensation which does not preclude treatment.

Overdose
Information not available

Recommended Dosage
 Lustra-AF should be applied to the affected areas twice daily, morning and before bedtime, or as directed by a physician. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.

Supplied / Packaging
Each g of topical cream contains: hydroquinone 4% USP (w/w), octyl methoxycinnamate 7.5% USP (w/w) and avobenzone 3% USP (w/w) (in moisturizing base). Nonmedicinal ingredients: a-tocopherol, ascorbic acid, ascorbyl palmitate, benzyl alcohol, butylated hydroxytoluene, C 13-14 isoparaffin, carbomer, ceteareth-20, cetearyl alcohol, cetyl alcohol, cyclopentasiloxane, dimethiconol, disodium EDTA, ethyl alcohol, fragrance, glycerin 99% USP, glyceryl stearate, glycolic acid, hydrogenated lecithin, laureth-7, linoleic acid, PEG-100 stearate, phenoxyethanol, phenyl trimethicone, polysilicone-11, polyacrylamide, purified water, sodium citrate, sodium metabisulfite, triethanolamine 99% and tocopheryl acetate. Jars of 28.4g. Store between 15 and 25°C.

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