Label: ELASTIDERM DECOLLETAGE SKIN LIGHTENING COMPLEX CHEST AND NECK- hydroquinone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 62032-120-60 - Packager: OMP, INC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated June 23, 2014
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- SPL UNCLASSIFIED SECTION
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SPL UNCLASSIFIED SECTION
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:
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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.
- Indications and Usage:
- Contraindications:
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Dosage and Administration:
A thin application should be applied once or 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 sunblocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
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Warnings:
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 within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, the product should be discontinued and a physician consulted. Close patient supervision is recommended.
Avoid contact with the eyes, nose, mouth, and lips. In case of accidental contact, the 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.
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.
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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 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:
- How Supplied:
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 57 g Carton
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INGREDIENTS AND APPEARANCE
ELASTIDERM DECOLLETAGE SKIN LIGHTENING COMPLEX CHEST AND NECK
hydroquinone lotionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-120 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TROLAMINE SALICYLATE (UNII: H8O4040BHD) LACTIC ACID (UNII: 33X04XA5AT) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM METABISULFITE (UNII: 4VON5FNS3C) ASCORBIC ACID (UNII: PQ6CK8PD0R) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color GRAY Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-120-60 1 in 1 CARTON 1 57 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/01/2010 Labeler - OMP, INC. (790553353) Establishment Name Address ID/FEI Business Operations PureTek Corporation 785961046 MANUFACTURE(62032-120) , LABEL(62032-120) , PACK(62032-120)
