EpiQuin Micro

Avoid exposure to sunlight or tanning beds. Hydroquinone topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Some hydroquinone products may contain sunscreen. Check the medicine label or ask your doctor to be sure.

Avoid getting this medicine in your eyes.

Hydroquinone topical may make your skin more sensitive to weather extremes such as cold and wind. Protect your skin with clothing and use a moisturizing lotion as needed.

Using hydroquinone topical together with benzoyl peroxide, hydrogen peroxide, or other peroxide products may stain your skin. This staining can usually be removed with soap and water.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

• It is used to lighten the skin where there are changes in color.

• If you have an allergy to hydroquinone or any other part of EpiQuin Micro (hydroquinone).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about EpiQuin Micro, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about EpiQuin Micro. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using EpiQuin Micro.

Review Date: October 4, 2017

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.

Applies to hydroquinone topical: topical combination cream, topical cream gel emulsion or solution

Side effects include:

Mild skin irritation and sensitization (e.g., burning, erythema, stinging).