OBAGI-C RX SYSTEM NORMAL-OILY SKIN INTERVENTION

OBAGI-C RX SYSTEM NORMAL-OILY 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-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.

OBAGI-C RX SYSTEM NORMAL-OILY 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 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.

OBAGI-C RX SYSTEM NORMAL-OILY 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
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