Obagi – C

OBAGI — C — hydroquinone liquid
YS PLUS CORPORATION

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.

WELCOME TO THE OBAGI — C RX SYSTEM OF SKIN CARE PRODUCTS!

For external use only

Rx only

For topical use only

Help correct early signs of aging and skin damage before they become a problem! This early

intervention system helps keep your skin protected and proactively addresses emerging signs of

skin dmaage to refresh and maintain youthful, healthy — looking skin. The Obagi — C Rx System is a

unique skin care regumen that combines the benefits of both prescription — strength

hydroquinone and the power of Vitamin — C.

Please read this product infomration 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 at our website at

www.obagi.com.

Each gram of Obagi — C Rx System C — Clarifying Serum for Normal to Dry Skin contains:

Active ingredient:

Hydroquinone USP, 4 % (40 mg / g)

Inactive Ingredients:

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

Each gram of Obagi — C Rx System C — Clarifying Serum for Normal to Oily Skin 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

Each gram of Obagi — C Rx System 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

Hydroquinone is 1,4 — bensenediol. 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 / moL.

Topical application of hydroquinone produces a reversible depigmentation of the skin by

inhibition of the enzymatic oxidation of 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

sunblocking agents or sunscreen agents contained in the Obagi — C Rx System sun Shield Matte

Broad Spectrum SPF 50.

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles,

senile lentigines, and other unwanted areas of melanin hyperpigmentation.

A thin application should be applied once or twice daily or as directed by a physician. no

improvement is seen after three (3) months of treatment, use of this product should be

discontinued. Sun exposure may be limited by using a sunscreen agent, a sunblocking agent,

or protective clothing to cover bleached skin when using and after using this product in order to

prevent darkening from reoccuring.

Hydroquinoone 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, product should be discontinued and

physician consulted. Close patient supervision is recommended.

Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, 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 Therapy Night Cream 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 populationis unknown and probably low. Sulfite sensitivity is seen

more frequently in asthmatic than in nonasthmatic people.

(also 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 Category C

Animal reproduction studies have not been conducted with topical hydroquinone. It is also

not known whether hydroquinone can case 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.

Nursing Mothers

It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is

advised when topical hydroquinone is used by a nursing mother.

Pediatric Usage

Safety and effectiveness in children below the age of 12 years have not been established.

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.

People with prior history of sensitivity or allergic reaction to this product or any of its

ingredients should not use it. The safety of topical hydroquinone use during pregnancy

or in children (12 years and under) has not been established.

Store at controlled room temperature 15 C — 25 C (59 F — 77 F). Keep out of direct sunlight

copy of label
(click image for full-size original)

OBAGI — C hydroquinone liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69269-105
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
WATER
GLYCERIN
CETYL ALCOHOL
PPG-2 MYRISTYL ETHER PROPIONATE
SODIUM LAURYL SULFATE
TROLAMINE SALICYLATE
LACTIC ACID
PHENYL TRIMETHICONE
.ALPHA.-TOCOPHEROL ACETATE
SODIUM DITHIONATE
ASCORBIC ACID
METHYLPARABEN
EDETATE DISODIUM
PROPYLPARABEN
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69269-105-36 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 10/01/2014
Labeler — YS PLUS CORPORATION (843007597)
Establishment
Name Address ID/FEI Operations
YS PLUS CORPORATION 843007597 repack (69269-105)

Revised: 10/2014 YS PLUS CORPORATION

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