Obagi C Rx System Skin Intervention

Generic Name: hydroquinone, octinoxate and zinc oxide
Dosage Form: topical kit

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.

OBAGI-C® RX SYSTEM NORMAL-OILY
SKIN INTERVENTION KIT

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

Use twice daily, morning and evening. Massage a small amount of cleanser and lukewarm water onto skin, rubbing gently in a circular motion. Rinse completely with lukewarm water and gently pat dry.

Warnings

Avoid getting into eyes. For external use only.

Keep out of reach of children.

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)

C-Balancing Toner 6.7 fl. oz. (198 mL.) AM+PM

Specifically formulated for normal to oily skin, the C-Balancing Toner adjusts your skin's pH balance. As an essential step after cleansing, this alcohol-free, non-drying toner thoroughly removes impurities and dead skin cells to prepare the skin for the next step in your skin care regimen. s.

Directions

Use twice daily, in the morning and evening after cleansing. Pump a small amount (3-4 pumps) onto a cotton pad and gently wipe over entire face. Let air dry. Do not rinse.

Warnings

Avoid getting into eyes. For external use only.

Keep out of reach of children.

Ingredients

water (aqua), hamamelis virginiana (witch hazel) water, propylene glycol, sodium pca, benzalkonium chloride, aloe barbadensis leaf juice (aloe barbadensis), panthenol, polyquaternium-10, phenoxyethanol, methylparaben

C-Clarifying Serum Normal to Oily (Skin Lightening Serum) NDC 62032-122-10 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 oily skin reduces the appearance of dark spots for a lighter, brighter complexion.

Indications and usage

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

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.

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 Oily contains:

Active Ingredient

Hydroquinone USP, 4% (40 mg/g)

Inactive Ingredients

water, propylene glycol, alcohol denat., dipropylene glycol, ascorbic acid, propylene carbonate, sodium lauryl sulfate, fragrance

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

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

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

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

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.

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

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

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

Travel Bag and Patient Instruction Guide

Sun Shield Broad Spectrum SPF 50 Matte
Net wt. 3 oz. (85 g)

This sunscreen combines UVB absorption and UVA protection in an elegant matte finish that is non-comedogenic, hypoallergenic, non-acnegenic, and dermatologist tested. Sheer, PABA free, and fragrance free for all skin types.

Drug Facts

Active ingredients Purpose
Octinoxate 7.5% Sunscreen
Zinc Oxide 10.5% Sunscreen

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

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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
  • 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

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

  • store at controlled room temperature: 15°C–25°C (59°F–77°F)
  • protect this product from excessive heat and direct sun

Questions or comments?

1.800.636.7546
Monday–Friday 9 a.m.–4 p.m. Pacific Time

Store at controlled room temperature 15°C–25°C (59°F–77°F).

Obagi-C and the Obagi logo are registered trademarks of OMP, Inc.

Distributed by OMP, Inc., Long Beach, CA 90806

©2012 Obagi Medical Products, Inc. All rights reserved.
obagi.com Made in USA 41502111Z 5021

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC # 62032-523-04

OBAGI®
MEDICAL

OBAGI-C® RX SYSTEM

NORMAL OILY

Skin Intervention Kit

Established Pharmacological Class
Substance Pharmacological Class
OBAGI-C RX SYSTEM C-CLEANSINGWITH VITAMIN C Cleansing (cold creams, cleansing lotions, liquids, and pads)
OBAGI-C RX SYSTEM C-BALANCING TONERFOR NORMAL TO OILY SKIN Cleansing (cold creams, cleansing lotions, liquids, and pads)
OBAGI-C RX SYSTEM NORMAL-OILY  SKIN INTERVENTION
hydroquinone, octinoxate and zinc oxide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62032-523
Packaging
# Item Code Package Description
1 NDC:62032-523-04 1 KIT 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 198 mL
Part 1 of 5
OBAGI C RX SYSTEM C CLARIFYING SERUM 
hydroquinone liquid
Product Information
Item Code (Source) NDC:62032-122    
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL  
WATER  
ASCORBIC ACID  
SODIUM LAURYL SULFATE  
PROPYLENE CARBONATE  
ALCOHOL  
DIPROPYLENE GLYCOL  
Packaging
# Item Code Package Description
1 NDC:62032-122-10 1 BOTTLE, GLASS 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 01/01/2010
Part 2 of 5
OBAGI-C RX SYSTEM C-THERAPY   SKIN LIGHTENING WITH VITAMINS C AND E
hydroquinone cream
Product Information
Item Code (Source) NDC:62032-105    
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM  
PPG-2 MYRISTYL ETHER PROPIONATE  
TROLAMINE SALICYLATE  
SODIUM LAURYL SULFATE  
CETYL ALCOHOL  
GLYCERIN  
LACTIC ACID  
.ALPHA.-TOCOPHEROL ACETATE  
ASCORBIC ACID  
SODIUM METABISULFITE  
WATER  
METHYLPARABEN  
PROPYLPARABEN  
BUTYLATED HYDROXYTOLUENE  
PHENYL TRIMETHICONE  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
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 lotion
Product Information
Item Code (Source) NDC:62032-121    
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg  in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 105 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5  
WATER  
GLYCERIN  
PHENOXYETHANOL  
PEG-10 DIMETHICONE (600 CST)  
PENTYLENE GLYCOL  
STEARYL ALCOHOL  
POLYOXYL 20 CETOSTEARYL ETHER  
PHENYL TRIMETHICONE  
PEG-40 STEARATE  
DIMETHICONE  
SODIUM DIHYDROXYCETYL PHOSPHATE  
HYDROGENATED PALM GLYCERIDES  
CITRIC ACID MONOHYDRATE  
CETOSTEARYL ALCOHOL  
.ALPHA.-TOCOPHEROL ACETATE  
1,2-HEXANEDIOL  
CAPRYLYL GLYCOL  
TROPOLONE  
CHLORPHENESIN  
XANTHAN GUM  
POTASSIUM SORBATE  
SODIUM BENZOATE  
TETRAHEXYLDECYL ASCORBATE  
UBIDECARENONE  
EDETATE DISODIUM  
METHYLISOTHIAZOLINONE  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)  
SQUALANE  
POLYSORBATE 60  
SODIUM POLYACRYLATE (2500000 MW)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
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 02/12/2013
Part 4 of 5
OBAGI-C RX SYSTEM C-CLEANSING  WITH VITAMIN C
inert gel
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Ingredients
Ingredient Name Quantity
WATER  
GLYCERIN  
PHENOXYETHANOL  
ETHYLPARABEN  
ISOBUTYLPARABEN  
BUTYLPARABEN  
PROPYLPARABEN  
METHYLPARABEN  
ASCORBIC ACID  
SODIUM LAUROYL OAT AMINO ACIDS  
COCAMIDOPROPYL BETAINE  
SODIUM LAURETH-3 SULFATE  
ALOE VERA LEAF  
SODIUM CHLORIDE  
ALFALFA  
CHAMOMILE  
XANTHAN GUM  
D&C RED NO. 33  
FD&C YELLOW NO. 5  
Product Characteristics
Color ORANGE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
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-BALANCING TONER  FOR NORMAL TO OILY SKIN
inert liquid
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Ingredients
Ingredient Name Quantity
WATER  
METHYLPARABEN  
PHENOXYETHANOL  
PROPYLENE GLYCOL  
ALOE VERA LEAF  
HAMAMELIS VIRGINIANA TOP WATER  
BENZALKONIUM CHLORIDE  
SODIUM PYRROLIDONE CARBOXYLATE  
POLYQUATERNIUM-10 (400 MPA.S At 2%)  
Packaging
# Item Code Package Description
1 198 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 01/01/2009
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 Operations
PURETEK CORPORATION 785961046 MANUFACTURE(62032-523), LABEL(62032-523), PACK(62032-523)
Establishment
Name Address ID/FEI Operations
Ei INC. 105803274 MANUFACTURE(62032-523), LABEL(62032-523), PACK(62032-523), ANALYSIS(62032-523)
Establishment
Name Address ID/FEI Operations
MILBAR LABORATORIES 195556790 MANUFACTURE(62032-523)
Establishment
Name Address ID/FEI Operations
Bay Cities Container Corporation 066229618 RELABEL(62032-523), REPACK(62032-523)
Establishment
Name Address ID/FEI Operations
Swiss-American Products 611921669 MANUFACTURE(62032-523)
Revised: 08/2013
 
OMP, INC.



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