Label: NU-DERM CLEAR SKIN BLEACHING AND CORRECTOR- hydroquinone cream
NU-DERM BLENDER SKIN LIGHTENER AND BLENDING- hydroquinone cream
NU-DERM SUNFADER SKIN LIGHTENER WITH SUNSCREEN (SPF 15) PABA FREE- hydroquinone, octinoxate, and oxybenzone lotion
- NDC Code(s): 62032-100-10, 62032-100-36, 62032-101-36, 62032-116-36
- Packager: Obagi Cosmeceuticals LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated November 12, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
-
DESCRIPTION
Hydroquinone is 1, 4-benzenediol. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designed as p-dihydroxybenzene; the empirical formula is C6H6O2; molecular weight is 110.11 g/mol. The chemical structure is in the diagram below.
Each gram of Obagi Nu-Derm Clear contains:
Active ingredient: Hydroquinone USP, 4% (40 mg/g)
Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben
Each gram of Obagi Nu-Derm Blender 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
Each gram of Obagi Nu-Derm Sunfader contains:
Active ingredients: Hydroquinone USP, 4% (40 mg/g); Octinoxate USP, 7.5%; Oxybenzone USP, 5.5%
Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, saponins, propylparaben, butylparaben
-
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 Nu-Derm Sunfader and Obagi Nu-Derm Sun Shield Matte Broad Spectrum SPF 50.
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
-
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 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.
Warnings: 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.
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.
-
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
-
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.
-
HOW SUPPLIED
Obagi Nu-Derm Clear is available as follows:
Net wt. 2 oz. (57 g) bottle
NDC 62032-101-36Obagi Nu-Derm Blender is available as follows:
Net wt. 2 oz. (57 g) bottle
NDC 62032-100-36Net wt. 1 oz. (28 g) bottle
NDC 62032-100-10Obagi Nu-Derm Sunfader is available as follows:
Net wt. 2 oz. (57 g) bottle
NDC 62032-116-36 - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 3
- PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 5
- PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 6
-
INGREDIENTS AND APPEARANCE
NU-DERM CLEAR SKIN BLEACHING AND CORRECTOR
hydroquinone creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-101 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) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-101-36 57 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/1988 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/1988 NU-DERM BLENDER SKIN LIGHTENER AND BLENDING
hydroquinone creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-100 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, UNSPECIFIED FORM (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 WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-100-10 28 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/1988 2 NDC:62032-100-36 57 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/1988 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/1988 NU-DERM SUNFADER SKIN LIGHTENER WITH SUNSCREEN (SPF 15) PABA FREE
hydroquinone, octinoxate, and oxybenzone lotionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-116 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 OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 55 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-116-36 57 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/1984 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/1984 Labeler - Obagi Cosmeceuticals LLC (790553353) Establishment Name Address ID/FEI Business Operations PureTek Corporation 785961046 MANUFACTURE(62032-101, 62032-100, 62032-116) , LABEL(62032-101, 62032-100, 62032-116) , PACK(62032-101, 62032-100, 62032-116) Establishment Name Address ID/FEI Business Operations G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE(62032-101, 62032-100)