Label: OBAGI-C RX SYSTEM NORMAL-DRY SKIN INTERVENTION- hydroquinone, homosalate, octisalate, and zinc oxide kit
- NDC Code(s): 62032-535-04
- 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 January 26, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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PATIENT INFORMATION—For Topical Use Only
Complete skin care regimen formulated with 4% hydroquinone to reduce hyperpigmentation and other essential ingredients to help address the signs of skin aging caused by photoaging.
Please read this product information 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 on our website at www.obagi.com.
- PHYSICIAN PRESCRIBING INFORMATION
- 62032-106-10 Obagi-C® Rx System C-Clarifying Serum for Normal to Dry Skin
- 62032-122-10 Obagi-C® Rx System C-Clarifying Serum for Normal to Oily Skin
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62032-105-36 Obagi-C® Rx System C-Therapy Night Cream
Each gram of Obagi-C® Rx System C-Therapy Night Cream contains:
Active: Hydroquinone, USP 4% (40 mg per g)
Inactives: ascorbic acid, BHT, cetyl alcohol, disodium EDTA, glycerin, lactic acid, methylparaben, phenyl trimethicone, PPG-2 myristyl ether propionate, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfate, TEA-salicylate, tocopheryl acetate, water
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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 C6H6O2; molecular weight is 110.11 g per mol.
The chemical structure is in the diagram.
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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 sunscreen agents contained in the Obagi-C® Rx System Sun Shield Matte Broad Spectrum SPF 50.
- INDICATIONS AND USAGE
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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 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 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, the product should be discontinued and a physician consulted. Close patient supervision is recommended.
- Avoid contact with 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.
The Obagi-C® Rx System C-Therapy Night Cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and lifethreatening 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
(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
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.
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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.
To report SUSPECTED ADVERSE REACTIONS, contact Obagi Cosmeceuticals LLC, at 1-800-636-7546 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- CONTRAINDICATIONS
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HOW SUPPLIED
Obagi-C® Rx System C-Clarifying Serum
(Hydroquinone, USP 4%) for Normal to Dry Skin is available as follows:1 fl. oz. (30 mL) bottle
NDC 62032-106-10Obagi-C® Rx System C-Clarifying Serum
(Hydroquinone, USP 4%) for Normal to Oily Skin is available as follows:1 fl. oz. (30 mL) bottle
NDC 62032-122-10Obagi-C® Rx System C-Therapy Night Cream
(Hydroquinone, USP 4%) is available as follows:Net wt. 2 oz. (57 g) bottle
NDC 62032-105-36 -
SPL UNCLASSIFIED SECTION
Distributed by Obagi Cosmeceuticals LLC,
Long Beach, CA 90806U.S. Patent 6,299,889
All products/brand names, whether
designated by notice or not (®/TM), are
trademarks of Obagi Cosmeceuticals LLC
and/or its affiliates.©2019 Obagi Cosmeceuticals LLC.
All rights reserved.
www.obagi.com
9578903 Revised: 1/2019 - Sun Shield Matte Broad Spectrum SPF 50Net wt. 3 oz. (85 g) AM
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- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.–2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- Other information
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Inactive ingredients
Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
OBAGI-C RX SYSTEM NORMAL-DRY SKIN INTERVENTION
hydroquinone, homosalate, octisalate, and zinc oxide kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-535 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-535-04 1 in 1 CARTON 12/02/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, GLASS 30 mL Part 2 1 BOTTLE, PLASTIC 57 g Part 3 1 TUBE 85 g Part 4 1 BOTTLE, PLASTIC 177 mL Part 5 1 BOTTLE, PLASTIC 57 g Part 1 of 5 OBAGI-C RX SYSTEM C-CLARIFYING SERUM SKIN LIGHTENING SERUM WITH VITAMIN C
hydroquinone liquidProduct Information 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 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) PROPYLENE CARBONATE (UNII: 8D08K3S51E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/2004 Part 2 of 5 OBAGI-C RX SYSTEM C-THERAPY NIGHT SKIN LIGHTENING WITH VITAMINS C AND E
hydroquinone creamProduct Information 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) PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) TROLAMINE SALICYLATE (UNII: H8O4040BHD) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CETYL ALCOHOL (UNII: 936JST6JCN) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 57 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/2004 Part 3 of 5 OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN
homosalate, octisalate, and zinc oxide lotionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 165 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Hydroxyacetophenone (UNII: G1L3HT4CMH) XANTHAN GUM (UNII: TTV12P4NEE) Sodium Chloride (UNII: 451W47IQ8X) Sodium Hydroxide (UNII: 55X04QC32I) Octyldodecyl Neopentanoate (UNII: X8725R883T) Triethoxycaprylylsilane (UNII: LDC331P08E) C15-19 Alkane (UNII: CI87N1IM01) Disteardimonium Hectorite (UNII: X687XDK09L) Sorbitan Olivate (UNII: MDL271E3GR) DIMETHICONE (UNII: 92RU3N3Y1O) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM (UNII: 7FLD91C86K) Candelilla Wax (UNII: WL0328HX19) Yellow Wax (UNII: 2ZA36H0S2V) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) Silicon Dioxide (UNII: ETJ7Z6XBU4) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 85 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/02/2019 Part 4 of 5 OBAGI-C RX SYSTEM C-CLEANSING WITH VITAMIN C
cleansing (cold creams, cleansing lotions, liquids, and pads) gelProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR ETHYLPARABEN (UNII: 14255EXE39) INGR ISOBUTYLPARABEN (UNII: 0QQJ25X58G) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) INGR ASCORBIC ACID (UNII: PQ6CK8PD0R) INGR SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD) INGR CHAMOMILE (UNII: FGL3685T2X) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR D&C RED NO. 33 (UNII: 9DBA0SBB0L) INGR BORAGE (UNII: PB618V0K2W) Product Characteristics color ORANGE C48331 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/01/2004 Part 5 of 5 OBAGI-C RX SYSTEM C-EXFOLIATING DAY WITH VITAMIN C
face and neck (excluding shaving preparations) lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR ETHYLPARABEN (UNII: 14255EXE39) INGR ISOBUTYLPARABEN (UNII: 0QQJ25X58G) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR ETHYLHEXYL PALMITATE (UNII: 2865993309) INGR SQUALANE (UNII: GW89575KF9) INGR HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) INGR PEG-8 DIMETHICONE (UNII: GIA7T764OD) INGR PEG-8 RICINOLEATE (UNII: DM36F4D2OU) INGR GLYCOLIC ACID (UNII: 0WT12SX38S) INGR ARGININE (UNII: 94ZLA3W45F) INGR ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR STEARETH-2 (UNII: V56DFE46J5) INGR ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) INGR LEVOMENOL (UNII: 24WE03BX2T) INGR EDETATE SODIUM (UNII: MP1J8420LU) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Product Characteristics color WHITE C48325 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 57 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/02/2004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 12/02/2019 Labeler - Obagi Cosmeceuticals LLC (790553353) Establishment Name Address ID/FEI Business Operations G. S. Cosmeceutical USA, Inc. 017014734 MANUFACTURE(62032-535) Establishment Name Address ID/FEI Business Operations Universal Packaging Systems, Inc. (DBA Paklab) 177711082 MANUFACTURE(62032-535) , PACK(62032-535) Establishment Name Address ID/FEI Business Operations Swiss American CDMO, LLC 080170933 MANUFACTURE(62032-535) Establishment Name Address ID/FEI Business Operations PURETEK CORPORATION 785961046 MANUFACTURE(62032-535) , LABEL(62032-535) , PACK(62032-535)