OBAGI-C RX SYSTEM NORMAL-DRY SKIN INTERVENTION: Package Insert and Label Information

OBAGI-C RX SYSTEM NORMAL-DRY SKIN INTERVENTION- hydroquinone, octinoxate and zinc oxide
OMP, INC.

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.

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-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.

OBAGI-C RX SYSTEM NORMAL-DRY SKIN INTERVENTION 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 Dry contains:

Active Ingredient

Hydroquinone USP, 4% (40 mg/g)

Inactive Ingredients

propylene glycol, water, ascorbic acid, propylene carbonate, sodium lauryl sulfate.

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

C-Exfoliating Day Lotion Net wt. 2 oz. (57 g.) AM

A smooth, lightweight moisturizer that not only hydrates, but also gently exfoliates the skin, revealing a brighter, healthier-looking complexion.

Directions

Use once daily in the morning. Squeeze a small amount (approximately 1-2 pea-sized drops) onto your hands. Using your fingertips, apply evenly to the entire face. Massage gently until completely absorbed.

Warnings

Avoid getting into eyes. For external use only.

Keep out of reach of children.

Sunburn Alert

This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

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)

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.

OBAGI-C RX SYSTEM NORMAL-DRY SKIN INTERVENTION 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 41502211Z 5022

PRINCIPAL DISPLAY PANEL — Kit Carton

NDC# 62032-524-04

OBAGI®
MEDICAL

OBAGI-C® RX SYSTEM

NORMAL DRY
Skin Intervention Kit

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
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-EXFOLIATING DAYWITH VITAMIN C Face and Neck (excluding shaving preparations)
OBAGI-C RX SYSTEM NORMAL-DRY SKIN INTERVENTION
hydroquinone, octinoxate and zinc oxide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-524
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-524-04 1 KIT in 1 CARTON None
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 liquid
Product Information
Item Code (Source) NDC:62032-106
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-106-10 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 30 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (62032-106-10)
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 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 Multilevel Packaging
1 NDC:62032-105-36 57 g in 1 BOTTLE, PLASTIC None
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
GLYCERIN
PHENOXYETHANOL
CYCLOMETHICONE 5
WATER
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 Multilevel Packaging
1 NDC:62032-121-90 85 g in 1 TUBE None
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
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 Multilevel Packaging
1 177 mL in 1 BOTTLE, PLASTIC None
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
inert lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
PHENOXYETHANOL
ETHYLPARABEN
ISOBUTYLPARABEN
BUTYLPARABEN
PROPYLPARABEN
METHYLPARABEN
POLYSORBATE 60
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
ETHYLHEXYL PALMITATE
SQUALANE
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)
PEG-8 DIMETHICONE
PEG-8 RICINOLEATE
GLYCOLIC ACID
ARGININE
ETHYLHEXYL STEARATE
MEDIUM-CHAIN TRIGLYCERIDES
ISOPROPYL PALMITATE
HYALURONATE SODIUM
SODIUM HYDROXIDE
CETOSTEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
DIMETHICONE
STEARETH-2
ASCORBYL GLUCOSIDE
LEVOMENOL
EDETATE SODIUM
.ALPHA.-TOCOPHEROL ACETATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 57 g in 1 BOTTLE, PLASTIC None
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 Operations
PURETEK CORPORATION 785961046 MANUFACTURE (62032-524), LABEL (62032-524), PACK (62032-524)
Establishment
Name Address ID/FEI Operations
Ei INC. 105803274 MANUFACTURE (62032-524), LABEL (62032-524), PACK (62032-524), ANALYSIS (62032-524)
Establishment
Name Address ID/FEI Operations
MILBAR LABORATORIES 195556790 MANUFACTURE (62032-524)
Establishment
Name Address ID/FEI Operations
Bay Cities Container Corporation 066229618 RELABEL (62032-524), REPACK (62032-524)

Revised: 08/2013 OMP, INC.

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