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 Sunbalance or any of the other ingredients. The safety of topical treatment of Sunbalance during pregnancy or in children (12 years and under) has not been established..
WARNINGS
Sunbalance 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. If no improvement is seen after two months of treatment, use of this product should be discontinued.
Sunscreen use is an essential aspect of Sunbalance 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.
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PRECAUTIONS
Pregnancy Category C
Animal reproduction studies have not been conducted with Sunbalance. It is also not known whether Sunbalance 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 Sunbalance is absorbed systemically. Topical Sunbalance should be used in pregnant women only when clearly indicated.
Nursing Mothers
It is not known whether topical administration of Sunbalance is absorbed or excreted in human milk. Caution is advised when topical Sunbalance 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 Sunbalance 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.
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.
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HOW SUPPLIED
ALPHAQUIN® HP 4% CREAM 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.. Protect from freezing. If freezing occurs, warm to room temperature.
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
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Sunbalance pharmaceutical active ingredients containing related brand and generic drugs:
Dailymed."FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
Dailymed."OXYBENZONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
Frequently asked Questions
Can i drive or operate heavy machine after consuming Sunbalance?
Depending on the reaction of the Sunbalance after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Sunbalance not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Sunbalance addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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Review
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