OBAGI - C (HYDROQUINONE) LIQUID [YS PLUS CORPORATION]

OBAGI - C (HYDROQUINONE) LIQUID [YS PLUS CORPORATION]
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NDC 69269-106-10
Set ID d3806180-c3d5-43c7-b1f8-91c29e2789ad
Category HUMAN PRESCRIPTION DRUG LABEL
Packager YS PLUS CORPORATION
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    WELCOME TO THE OBAGI - C RX SYSTEM OF SKIN CARE PRODUCTS!

    For external use only

    Rx only

  • PATIENT MEDICATION INFORMATION

    For topical use only

    Help correct early signs of aging and skin damage before they become a problem! This early

    intervention system helps keep your skin protected and proactively addresses emerging signs of

    skin dmaage to refresh and maintain youthful, healthy - looking skin. The Obagi - C Rx System is a

    unique skin care regumen that combines the benefits of both prescription - strength

    hydroquinone and the power of Vitamin - C.

    Please read this product infomration prior to use of the Obagi - C Rx System. Any questions

    regarding your particular skin care regimen should be directed to your physician. More

    information about the Obagi - C Rx System or other Obagi systems is available at our website at

    www.obagi.com.

  • INFORMATION FOR PATIENTS

    Each gram of Obagi - C Rx System C - Clarifying Serum for Normal to Dry Skin contains:

    Active ingredient:

    Hydroquinone USP, 4 % (40 mg / g)

    Inactive Ingredients:

    propylene glycol, water, ascorbic acid, propylene carbonate, sodium lauryl sulfate

    Each gram of Obagi - C Rx System C - Clarifying Serum for Normal to Oily Skin contains:

    Active Ingredient:

    Hydroquinone USP, 4 % (40 mg / g)

    Inactive ingredients:

    water, propylene glycol, alcohol denat., dipropylene glycol, ascorbic acid, propylene carbonate,

    sodium lauryl sulfate, fragrance

    Each gram of Obagi - C Rx System C - Therapy Night Cream contains:

    Active ingredient:

    Hydroquinone USP, 4 % (40 mg / g)

    Inactive Ingredients:

    water, glycerin, cetyl alcohol, PPG - 2 myristyl ether propionate, sodium lauryl sulfate, TEA -

    salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic

    acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT

  • DESCRIPTION

    Hydroquinone is 1,4 - bensenediol. Hydroquinone occurs as fine, white needles. The drug is freely

    soluble in water and in alcohol. Chemically, hydroquinone is designated as p - dihydroxybenzene;

    the empirical formula is C6H6O2; molecular weight is 110.11 g / moL.

  • CLINICAL PHARMACOLOGY

    Topical application of hydroquinone produces a reversible depigmentation of the skin by

    inhibition of the enzymatic oxidation of 3, 4 - dihydroxyphenylalanine (DOPA) and

    suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light

    will cause repigmentation of the bleached areas, which may be prevented by the use of

    sunblocking agents or sunscreen agents contained in the Obagi - C Rx System sun Shield Matte

    Broad Spectrum SPF 50.

  • INDICATIONS & USAGE

    The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles,

    senile lentigines, and other unwanted areas of melanin hyperpigmentation.

  • DOSAGE & ADMINISTRATION

    A thin application should be applied once or twice daily or as directed by a physician.  no

    improvement is seen after three (3) months of treatment, use of this product should be

    discontinued. Sun exposure may be limited by using a sunscreen agent, a sunblocking agent,

    or protective clothing to cover bleached skin when using and after using this product in order to

    prevent darkening from reoccuring.

  • WARNINGS

    Hydroquinoone is a skin - bleaching agent, which may produce unwanted cosmetic effects if not

    used as directed. The physician should be familiar with the contents of this insert before prescribing

    or dispensing this product.

    Test for skin sensitivity before using 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

    or vesicle formation or excessive inflammatory response, product should be discontinued and

    physician consulted. Close patient supervision is recommended.

    Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should

    rinse thoroughly with water and contact a physician.

    Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight

    exposure sustains melanocytic activity.

    The Obagi - C Rx Therapy Night Cream 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 populationis unknown and probably low. Sulfite sensitivity is seen

    more frequently in asthmatic than in nonasthmatic people.

  • PRECAUTIONS

    (also see WARNINGS)

    Treatment should be limited to relatively small areas of the body at one time since some

    patients experience a transient skin reddening and a mild burning sensation, which does not

    preclude treatment.

    Pregnancy Category C

    Animal reproduction studies have not been conducted with topical hydroquinone. It is also

    not known whether hydroquinone can case fetal harm when used topically on a pregnant woman

    or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is

    absorbed systemically. Topical hydroquinone should be used on pregnant women only when

    clearly indicated.

    Nursing Mothers

    It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is

    advised when topical hydroquinone is used by a nursing mother.

    Pediatric Usage

    Safety and effectiveness in children below the age of 12 years have not been established.

  • ADVERSE REACTIONS

    No systemic adverse reactions have been reported. Occasional hypersensitivity (localized

    contact dermatitis) may occur, in which case the product should be discontinued and physician

    notified immediately.

  • CONTRAINDICATIONS

    People with prior history of sensitivity or allergic reaction to this product or any of its

    ingredients should not use it. The safety of topical hydroquinone use during pregnancy

    or in children (12 years and under) has not been established.

  • STORAGE AND HANDLING

    Store at controlled room temperature 15 C - 25 C (59 F - 77 F). Keep out of direct sunlight

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    OBAGI - C  
    hydroquinone liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69269-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69269-106-101 in 1 CARTON
    130 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2014
    Labeler - YS PLUS CORPORATION (843007597)
    Establishment
    NameAddressID/FEIBusiness Operations
    YS PLUS CORPORATION843007597repack(69269-106)

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