Epiquin Micro

Generic Name: hydroquinone
Dosage Form: cream

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.

Epiquin Micro

EpiQum- Micro ts a patented. multi-phasic formulation containing 4 distinct phases - an oil phase. a water phase. and two methyl methacrylate/glycol dmethacrylate crosspolymer microparticulate phases resulting from the incorporation of two different MICROSPONG delivery systems within the formula. The formula contains 4% hydroquinone USP. apportioned in both the water phase (1.5%) and in one of the microparticulate phases (2.5%) of the formulation. It also includes retinol (vitamin A), which is shown to penetrate better than retinyl esters, in the second microparticulate phase. Using a standard model of topical drug release, the MICROSPQNGE delivery system has been shown to extend
the release of hydroquinone. The multi-phasic formulation aIows for the hydroquinone to be sequestered within the
two phases which allows for both immediate and gradual release of the active ingredient into the skin.The multi-phasic composition packaged in an airIess pump aIso improves the stabihty of the hydroquinone when compared to other formulations not containing the mictoparticulate, thus preserving the efficacy of the product. Hydroquinone is 1,4-benzenediol.Hydroquinone is structurally related to monobenzone.Hydroquinone occurs as fine white needles.The drug is freely soluble in water and in alcohol and has pK of 9.96.Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2; the molecular weigh is 110.1
Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3- (3.4-dihydroxyphenyl) alanine (dopa) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause
repigmentation of the bleached areas.
Pharmacocinetics: It is widely accepted that the absorption of a topicaly applied drug is affected by many factors, including the vehicle, the drug's soIubility, the conditions of the epidermis including the overall pH,disease state, and genetically driven factors such as oiliness of dryness of the epidermis.The rate of absorption can affect the efficacy and tolerability of the formulation.
Epiquin Micro is indicated for the gradual treatment of ultraviolet induced dyschromia and discoloration resulting from the use of or  contraceptives, pregnancy, hormone replacement therapy, or skin trauma.
Epiquin Micro is contraindicated in any patient with a prior history of hypersensitivity of allergic reaction to hydroquinone or any of the other ingredients. The safety of topical hydroquinone use during pregnancy or on chidren (1 2 years and under) has not been established.
A CAUTION: Hydroqurone is a depigmenting agent that may produce unwanted cosmetic effects if not used as directed. The physician should be familar with the contents of this insert before prescribing or dispensing this medication.B. Test for skin sensitivity before using Epiquin Micro 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. vesicle formation. or excessive inflammatory response. further treatment is not advised. Close patient supervision is recommended. Contact with the eves should be avoided. If no lightening effect is noted after two months of treatment, use of Epiquin Micro should be discontinued. C.Sunscreen use is an essential aspect of hydroquinone therapy, because even minimal sunlight sustains melanocytic activity. To prevent repigmentation during treatment and maintenance therapy. sun exposure on treated skin should be avoided by application of a broad spectrum
sunscreen (SPF 15 or greater) of by use of protective clothing. D. Keep this and aI medications out of reach of children. In case of accidental ingestion, contact a physician or a poison control center immediately. E. WARNING: Contains sodium metabisulfite,a sulfite that may cause serious allergic reactions (e.g., hives, itching, wheezing,anaphylaxis, severe asthma attack) in certain suscepllble persons.F. On rare occasions, a gradual blue-black darkening of the skin may occur, in which case, use of Epiquin Micro should be discontinued and a physician contacted immediately.
ADVERSE REACTIONS: No systemic reactions have been reported. Occasional cutaneous hypersensitivity (Iocalized contact dermatitis) may occur, in which case the medication should be discontinued and physician notified immediately.
 There have been no systemic reactions reported from the use of topical hydroquinone. However, treatment should be Iimited to reIatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild sensation that does not
preclude treatment.
EpiQun Micro should be applied to the affected areas twice daily, morning and before bedtime, or as directed by a physician. Replace cap after each use. To prevent repigmentation during and after the use of Epiquin Micro, sun exposure should be limited and a sunscreen agent or
sun-protective clothing should be used to cover the treated areas. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervison of a physician.
Epiquin Micro is supplied as follows:SIZE: 40 g tube with an airIess pump dispenser NDC NUMBER: 67402-010-40 Store at 25C (77F): excursions permitted to 15C- 30C (59F- 86F) (see USP Controled Room Temperature)

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A. Pregnancy Category C: Animal reproduction studies have not been conducted with topical hydroquinone. 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, topical hydroquinone is absorbed systemically.Topical hydroquinone Should be used in pregnant women only when clearly
indicated.
B. Nursing mothers: 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.
C. Pediatric usage: Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
Epiquin Micro 
hydroquinone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67402-010
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
hydroquinone (hydroquinone) hydroquinone 4 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ascorbic acid  
ascorbyl palmitate  
benzyl alcohol  
butylated hydroxytoluene  
LEVOMENOL  
C10-30 CHOLESTEROL/LANOSTEROL ESTERS  
C13-14 isoparaffin  
medium-chain triglycerides  
cetostearyl alcohol  
cetyl alcohol  
cetyl phosphate  
cyclomethicone 6  
CYCLOMETHICONE 5  
dimethicone  
edetate disodium  
glycerin  
laureth-7  
magnesium aluminum silicate  
methylparaben  
PEG-10 soy sterol  
Phenoxyethanol  
Polysorbate 20  
Polysorbate 60  
Propyl gallate  
Retinol  
Sodium metabisulfite  
trolamine stearate  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
trolamine  
water  
Packaging
# Item Code Package Description
1 NDC:67402-010-40 12 CARTON (CARTON) in 1 CASE
1 1 TUBE (TUBE) in 1 CARTON
1 40 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/21/2011
Labeler - SkinMedica, Inc. (124977005)
Registrant - Harmony Labs, Inc (105803274)
Establishment
Name Address ID/FEI Operations
Harmony Labs, Inc 105803274 pack, label
Establishment
Name Address ID/FEI Operations
AMCOL Health & Beauty Solution, Incorporated 872684803 manufacture
Revised: 08/2011
 
SkinMedica, Inc.



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