Label: CONDITION AND ENHANCE CLEAR SKIN BLEACHING AND CORRECTOR- hydroquinone cream
CONDITION AND ENHANCE BLENDER SKIN LIGHTENER AND BLENDING- hydroquinone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62032-115-10, 62032-115-36, 62032-117-36 - Packager: OMP, INC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 16, 2011
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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DESCRIPTION
Hydroquinone is 1,4-benzenediol. 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 C6 H6 O2; molecular weight is 110.0.
Obagi® Condition & Enhance Blender contains Hydroquinone USP 40 mg/gm in a base of purified 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, saponins, disodium EDTA, BHT, and propylparaben.
Obagi® Condition & Enhance Clear contains Hydroquinone USP 40 mg/gm in a base of purified water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, tocopheryl acetate, ascorbic acid, sodium metabisulfite, lactic acid, saponins, disodium EDTA, methylparaben, BHT, propylparaben, and butylparaben.
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CLINICAL PHARMACOLOGY
Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 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 Obagi Condition & Enhance.
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
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WARNINGS
Caution
Hydroquinone 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 medication.
Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.
Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. A bitter taste and anesthetic effect may occur if applied to lips.
Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.
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PRECAUTIONS
(SEE WARNINGS)
General
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 cause 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.
- ADVERSE REACTIONS
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DOSAGE AND ADMINISTRATION
A thin application should be applied to the affected area twice daily or as directed by a physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent repigmentation.
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 57 g Bottle Label
- PRINCIPAL DISPLAY PANEL - 57 g Bottle Label
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INGREDIENTS AND APPEARANCE
CONDITION AND ENHANCE CLEAR SKIN BLEACHING AND CORRECTOR
hydroquinone creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLPARABEN (UNII: 3QPI1U3FV8) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-117-36 57 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1988 CONDITION AND ENHANCE BLENDER SKIN LIGHTENER AND BLENDING
hydroquinone creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE SALICYLATE (UNII: H8O4040BHD) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-115-10 28.5 g in 1 BOTTLE, PLASTIC 2 NDC:62032-115-36 57 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1988 Labeler - OMP, INC. (790553353) Establishment Name Address ID/FEI Business Operations PURETEK CORPORATION 785961046 MANUFACTURE(62032-117, 62032-115) , LABEL(62032-117, 62032-115) , PACK(62032-117, 62032-115) Establishment Name Address ID/FEI Business Operations Ei INC. 105803274 MANUFACTURE(62032-117, 62032-115) , LABEL(62032-117, 62032-115) , PACK(62032-117, 62032-115) , ANALYSIS(62032-117, 62032-115)
