NDC | 62032-105-36, 62032-106-10, 62032-121-90, 62032-524-04 |
Set ID | d3b35a0e-cce3-4601-b18f-3e615e3bcd25 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | OMP, INC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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SPL UNCLASSIFIED SECTION
C-Cleansing Gel 6 fl. oz. (177 mL.) AM+PM
A gel-based facial cleanser that clarifies and prepares your skin for absorption of the system's product ingredients. This concentrated cleanser gently removes excess oil, makeup, and other everyday impurities, and rinses clean, leaving your skin feeling fresh and clear.
- Directions
- Warnings
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Ingredients
water (aqua), sodium laureth sulfate, sodium lauroyl oat amino acids, cocamidopropyl betaine, aloe barbadensis leaf juice (aloe barbadensis), ascorbic acid, glycerin, medicago sativa (alfalfa) extract, borago officinalis extract, chamomilla recutita (matricaria) flower extract (chamomilla recutita extract), sodium chloride, saponins, xanthan gum, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), red 33 (CI 17200), yellow 5 (CI 19140)
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SPL UNCLASSIFIED SECTION
C-Clarifying Serum Normal to Dry (Skin Lightening Serum) NDC 62032-106-10 1 fl. oz. (30 mL.) Hydroquinone USP, 4% Rx Only AM
Antioxidant serum containing Vitamin C and prescription-strength hydroquinone. This patented formulation for normal to dry skin reduces the appearance of dark spots for a lighter, brighter complexion.
- Indications and usage
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Dosage and administration
Use once daily in the morning. Apply 5-7 drops to the entire face, or as directed by your skin care physician. Massage in gently. 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 darkening from reoccurring.
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Warnings
Avoid contact with eyes, nose, mouth, or lips. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.
Each gram of Obagi-C Rx C-Clarifying Serum Normal to Dry contains:
- Active Ingredient
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Directions
- Warnings
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Ingredients
water (aqua), ethylhexyl palmitate, ethylhexyl stearate, glycolic acid, caprylic/capric triglyceride, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isopropyl palmitate, sodium hyaluronate, squalane, PEG-8 dimethicone, glyceryl stearate, PEG-100 stearate, glycerin, sodium hydroxide, PEG-8 ricinoleate, ascorbyl glucoside, tocopheryl acetate, dimethicone, arginine, cetearyl alcohol, ceteareth-20, steareth-2, bisabolol, tetrasodium EDTA, polysorbate 60, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum)
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SPL UNCLASSIFIED SECTION
C-Therapy Night Cream (Skin Lightener) NDC 62032-105-36 Net wt. 2 oz. (57 g.) Hydroquinone USP, 4% Rx Only PM
A rich moisturizer that works while you sleep to renew and rejuvenate your skin. The C-Therapy Night Cream is uniquely formulated with prescription-strength hydroquinone to gradually diminish the appearance of dark spots and delivers Vitamins C and E during the skin's nightly renewal process.
- Indications and usage
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Dosage and administration
Use daily in the evening. Dispense a small amount (approximately 1-2 pea-sized drops) and apply to the entire face. Massage in gently. 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 darkening from reoccurring.
- Warnings
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SPL UNCLASSIFIED SECTION
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.
Each gram of Obagi-C Rx C-Therapy Night Cream contains:
- Active Ingredient
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- 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
- children under 6 months: Ask a doctor
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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
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Inactive ingredients
1,2-hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone, dimethicone crosspolymer-3, disodium EDTA, glycerin, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-40 stearate, pentylene glycol, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, water, xanthan gum
- Other information
- Questions or comments?
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
OBAGI-C RX SYSTEM NORMAL-DRY SKIN INTERVENTION
hydroquinone, octinoxate and zinc oxide kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-524 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-524-04 1 in 1 CARTON 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 Item Code (Source) NDC:62032-106 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 NDC:62032-106-10 1 in 1 CARTON 1 30 mL in 1 BOTTLE, GLASS 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 SKIN LIGHTENING WITH VITAMINS C AND E
hydroquinone creamProduct Information Item Code (Source) NDC:62032-105 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) 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:62032-105-36 57 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/2004 Part 3 of 5 OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN
octinoxate and zinc oxide lotionProduct Information Item Code (Source) NDC:62032-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 105 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) WATER (UNII: 059QF0KO0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PENTYLENE GLYCOL (UNII: 50C1307PZG) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-40 STEARATE (UNII: ECU18C66Q7) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TROPOLONE (UNII: 7L6DL16P1T) CHLORPHENESIN (UNII: I670DAL4SZ) XANTHAN GUM (UNII: TTV12P4NEE) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) UBIDECARENONE (UNII: EJ27X76M46) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-121-90 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/21/2013 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 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 ALFALFA (UNII: DJO934BRBD) INGR CHAMOMILE (UNII: FGL3685T2X) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR D&C RED NO. 33 (UNII: 9DBA0SBB0L) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color ORANGE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 177 mL in 1 BOTTLE, PLASTIC 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 (45000 MPA.S AT 1%) (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 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 04/02/2013 Labeler - OMP, INC. (790553353) Establishment Name Address ID/FEI Business Operations PURETEK CORPORATION 785961046 MANUFACTURE(62032-524) , LABEL(62032-524) , PACK(62032-524) Establishment Name Address ID/FEI Business Operations Ei INC. 105803274 MANUFACTURE(62032-524) , LABEL(62032-524) , PACK(62032-524) , ANALYSIS(62032-524) Establishment Name Address ID/FEI Business Operations MILBAR LABORATORIES 195556790 MANUFACTURE(62032-524) Establishment Name Address ID/FEI Business Operations Bay Cities Container Corporation 066229618 RELABEL(62032-524) , REPACK(62032-524)