treatment with tretinoin.

as wind or cold, also may be irritating to patients under

when exposure cannot be avoided. Weather extremes, such
protective clothing over treated areas is recommended
particular caution. Use of sunscreen products and
with inherent sensitivity to the sun should exercise
considerable sun exposure due to occupation and those
use of tretinoin. Patients who may be required to have
heightened susceptibility to sunlight as a result of the
not to use the product until fully recovered because of
of tretinoin, and patients with sunburn should be advised
including sunlamps, should be minimized during the use
medication should be discontinued. Exposure to sunlight,
sensitivity or chemical irritation occurs, use of the

is noted.
discontinued if hypersensitivity to any of the ingredients

the treatment of other disorders have not been established. weakly carcinogenic light from a solar simulator. In other
safety and efficacy of the long-term use of this product in
topical application in the treatment of acne vulgaris. The

extrusion of the comedones.

increased turnover of follicular epithelial cells causing
Additionally, tretinoin stimulates mitotic activity and
epithelial cells with decreased microcomedo formation.
that topical tretinoin decreases cohesiveness of follicular
action of tretinoin is unknown, current evidence suggests

all-trans-retinoic acid and has the following structure:

hydroxytoluene, and purified water. Chemically, tretinoin is
stearyl alcohol, xanthan gum, sorbic acid, butylated
stearic acid, isopropyl myristate, polyoxyl 40 stearate,
0.025% by weight, in a hydrophilic cream vehicle of
tretinoin in either of three strengths, 0.1%, 0.05%, or
treatment of acne vulgaris. Tretinoin Cream contains

TRETINOIN CREAM
Precautions: General: If a reaction suggesting

Contraindications: Use of the product should be

Indications and Usage: Tretinoin is indicated for

Clinical Pharmacology: Although the exact mode of or lime should be used with caution because of possible

Description: Tretinoin Cream is used for the topical

20000283B
However, at these topical doses, delayed ossification of a
a 50 kg adult applies 250 mg of 0.1% cream topically).
320 times the topical human dose, respectively (assuming
in rats and rabbits when given in doses of 100 and

human dose.
fetotoxic in rats when given in doses 500 times the topical
topical human dose. Oral tretinoin has been shown to be
teratogenic in rats when given in doses 1000 times the

to sun.
is not clear, patients should avoid or minimize exposure
possible. Although the significance of these studies to man
conditions, no strict comparison of these disparate data is
was reduced. Due to significantly different experimental
the incidence and rate of development of skin tumors
tretinoin were exposed to carcinogenic doses of UVB light,
studies, when lightly pigmented hairless mice treated with

that tretinoin may accelerate the tumorigenic potential of

been performed. Studies in hairless albino mice suggest
determine the carcinogenic potential of tretinoin have not

before use of tretinoin is begun.

patient’s skin until the effects of such preparations subside
or salicylic acid with tretinoin. It also is advisable to “rest” a
exercised in using preparations containing sulfur, resorcinol,
interaction with tretinoin. Particular caution should be

with high concentrations of alcohol, astringents, spices

cosmetics that have a strong drying effect, and products
medicated or abrasive soaps and cleansers, soaps and

used with utmost caution in patients with this condition.

cause severe irritation on eczematous skin and should be
discontinue use altogether. Tretinoin has been reported to
medication less frequently, discontinue use temporarily, or
irritation warrants, patients should be directed to use the
and peeling at the site of application. If the degree of local
membranes. Topical use may induce severe local erythema
the eyes, the mouth, angles of the nose, and mucous
Topical tretinoin has not been shown to be teratogenic

Pregnancy: Oral tretinoin has been shown to be

Carcinogenesis: Long-term animal studies to

Drug Interactions: Concomitant topical medication,

Tretinoin acne treatment should be kept away from

For Topical Use Only
Remove this portion before dispensing

TRETINOIN CREAM PATIENT INSTRUCTIONS For Topical Use Only

Acne Treatment
IMPORTANT
Read Directions Carefully Before Using

THIS LEAFLET TELLS YOU ABOUT TRETINOIN ACNE experiencing severe or persistent irritation,
TREATMENT AS PRESCRIBED BY YOUR PHYSICIAN. discontinue the use of tretinoin and consult
THIS PRODUCT IS TO BE USED ONLY ACCORDING your physician.
TO YOUR DOCTOR’S INSTRUCTIONS, AND IT There have been reports that, in some patients,
SHOULD NOT BE APPLIED TO OTHER AREAS OF areas treated with tretinoin developed a temporary
THE BODY OR TO OTHER GROWTHS OR LESIONS. increase or decrease in the amount of skin pigment
THE LONG-TERM SAFETY AND EFFECTIVENESS OF (color) present. The pigment in these areas returned
THIS PRODUCT IN OTHER DISORDERS HAVE NOT to normal either when the skin was allowed to adjust
BEEN EVALUATED. IF YOU HAVE ANY QUESTIONS, to tretinoin or therapy was discontinued.
BE SURE TO ASK YOUR DOCTOR. Use other medication only on your
WARNINGS AND PRECAUTIONS physician’s advice. Only your physician knows
The effects of the sun on your skin. As you which other medications may be helpful during
know, overexposure to natural sunlight or the treatment and will recommend them to you if
artificial sunlight of a sunlamp can cause sunburn. necessary. Follow the physician’s instructions
Overexposure to the sun over many years may carefully. In addition, you should avoid preparations
cause premature aging of the skin and even skin that may dry or irritate your skin. These
cancer. The chance of these effects occurring preparations may include certain astringents,
will vary depending on skin type, the climate and toiletries containing alcohol, spices or lime, or
the care taken to avoid overexposure to the sun. certain medicated soaps, shampoos and hair
Therapy with tretinoin may make your skin more permanent solutions. Do not allow anyone else to
susceptible to sunburn and other adverse effects use this medication.
of the sun, so unprotected exposure to natural or Do not use other medications with tretinoin
artificial sunlight should be minimized. which are not recommended by your doctor. The
Laboratory findings. When laboratory mice medications you have used in the past might cause
are exposed to artificial sunlight, they often develop unnecessary redness or peeling.
skin tumors. These sunlight-induced tumors may If you are pregnant, think you are pregnant
appear more quickly and in greater number if the or are nursing an infant: No studies have
mouse is also topically treated with the active been conducted in humans to establish the
ingredient in Tretinoin Cream, tretinoin. In some safety of tretinoin in pregnant women. If you are
studies, under different conditions, however, pregnant, think you are pregnant, or are nursing
when mice treated with tretinoin were exposed a baby, consult your physician before using
to artificial sunlight, the incidence and rate of this medication.
development of skin tumors was reduced. There is
no evidence to date that tretinoin alone will cause AND WHILE YOU’RE ON TRETINOIN THERAPY
the development of skin tumors in either laboratory Use a mild, non-medicated soap. Avoid frequent
animals or humans. However, investigations in this washings and harsh scrubbing. Acne isn’t caused
area are continuing. by dirt, so no matter how hard you scrub, you can’t
wash it away. Washing too frequently or scrubbing
Use caution in the sun. When outside, even on too roughly may at times actually make your acne
hazy days, areas treated with tretinoin should be worse. Wash your skin gently with a mild, bland
protected. An effective sunscreen should be used soap. Two or three times a day should be sufficient.
any time you are outside (consult your physician Pat skin dry with a towel. Let the face dry 20 to
for a recommendation of an SPF level which 30 minutes before applying tretinoin. Remember,
will provide you with the necessary high level of excessive irritation such as rubbing, too much
protection). For extended sun exposure, protective washing, use of other medications not suggested
clothing, like a hat, should be worn. Do not use by your physician, etc., may worsen your acne.
artificial sunlamps while you are using tretinoin. If
you do become sunburned, stop your therapy with HOW TO USE TRETINOIN
tretinoin until your skin has recovered. To get the best results with tretinoin therapy,
Avoid excessive exposure to wind or cold. it is necessary to use it properly. Forget about the
Extremes of climate tend to dry or burn normal instructions given for other products and the advice
skin. Skin treated with tretinoin may be more of friends. Just stick to the special plan your doctor
vulnerable to these extremes. Your physician can has laid out for you and be patient. Remember,
recommend ways to manage your acne treatment when tretinoin is used properly, many users
under such conditions. see improvement by 12 weeks. AGAIN, FOLLOW
INSTRUCTIONS – BE PATIENT – DON’T START AND
Possible problems. The skin of certain STOP THERAPY ON YOUR OWN – IF YOU HAVE
sensitive individuals may become excessively QUESTIONS, ASK YOUR DOCTOR.
red, swollen, blistered or crusted. If you are
 number of bones occurred in both species. These changes
may be considered variants of normal development and are
usually corrected after weaning. There are no adequate and
well-controlled studies in pregnant women. Tretinoin should
be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether this drug is

if your skin is

skin. Be patient.
excreted in human milk. Because many drugs are excreted Therapeutic results should be noticed after two to

your physician.
in human milk, caution should be exercised when tretinoin three weeks but more than six weeks of therapy may be

or as directed by

advise, especially

every other night.

start your therapy
required before definite beneficial effects are seen.

sensitive, that you

is administered to a nursing woman.

Your physician may

• Apply tretinoin once

by applying tretinoin
daily before bedtime,
Adverse Reactions: The skin of certain sensitive Once the acne lesions have responded satisfactorily,
individuals may become excessively red, edematous, it may be possible to maintain the improvement with less
blistered, or crusted. If these effects occur, the medication frequent applications, or other dosage forms.
should either be discontinued until the integrity of the
skin is restored, or the medication should be adjusted to Patients treated with tretinoin acne treatment may

to minimize possible irritation.

use cosmetics, but the area to be treated should be

every morning after you wash.

a level the patient can tolerate. True contact allergy to

these simple instructions in mind.

topical tretinoin is rarely encountered. Temporary hyper- cleansed thoroughly before the medication is applied.
or hypopigmentation has been reported with repeated (see Precautions.)

for skin to be completely dry in order

application of tretinoin. Some individuals have been How Supplied:

APPLYING MEDICATION; it is important

and won’t give faster or better results.

may irritate the skin, waste medication
reported to have heightened susceptibility to sunlight while

invisible almost immediately. If it is still

Tretinoin is supplied as:

aggravate your acne (noncomedogenic)

suggested by your physician or to apply

• Cream: Squeeze about a half inch or less

under treatment with tretinoin. To date, all adverse effects

First, wash with a mild soap and dry your

visible, you are using too much. Cover the

first dabbing it on your forehead, chin and

affected area. Smooth gently into the skin.

more frequently than instructed. Too much

of medication onto the fingertip. While that

of tretinoin have been reversible upon discontinuance of

Tretinoin works deep inside your skin and this

you may find you need slightly more or less
should be enough for your whole face, after
of the nose, mouth, eyes and open wounds.
• It is better not to use more than the amount

• Keep the medication away from the corners

To help you use the medication correctly, keep

affected area lightly with Tretinoin Cream by

skin gently. WAIT 20 to 30 MINUTES BEFORE

or a moisturizer with sunscreen that will not

therapy (see Dosage and Administration).

to do the job. The medication should become

takes time. You cannot make tretinoin work any

both cheeks, then spreading it over the entire
Tretinoin Cream

faster by applying more than one dose each day,

Spread away from these areas when applying.

you have some experience with the medication

• It is recommended that you apply a moisturizer

Overdosage: If medication is applied excessively, no

but an excess amount of tretinoin may irritate your

WHAT TO EXPECT WITH YOUR NEW TREATMENT
more rapid or better results will be obtained and marked NDC Code Strength Quantity
redness, peeling, or discomfort may occur. Oral ingestion
of the drug may lead to the same side effects as those 62032-414-20 0.025% Cream 20 g
associated with excessive oral intake of Vitamin A.

By:
62032-412-20 0.05% Cream 20 g
Dosage and Administration: Tretinoin Cream should
be applied once a day, before retiring, to the skin where 62032-417-20 0.1% Cream 20 g
acne lesions appear, using enough to cover the entire

Remove this portion before dispensing

©OMP, Inc.
your doctor.
affected area lightly.

Rev. 03/2017
Storage Conditions: Tretinoin Cream, 0.1%, 0.05%, and

using tretinoin.
Application may cause a transitory feeling of warmth 0.025%: store below 80°F.

www.obagi.com
or slight stinging. In cases where it has been necessary to
Rx only

Manufactured for:
temporarily discontinue therapy or to reduce the frequency

up with your doctor.

of application, therapy may be resumed or frequency of Manufactured for:

signs of improvement.

9441001 20000283B
application increased when the patients become able to Obagi Medical Products, a division of
tolerate the treatment. Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

Alterations of vehicle, drug concentration, or Bridgewater, NJ 08807 USA

physician instructs otherwise.

dose frequency should be closely monitored by careful By:

Laval, Quebec H7L 4A8, Canada

observation of the clinical therapeutic response and Valeant Pharmaceuticals International, Inc.
skin tolerance. Laval, Quebec H7L 4A8, Canada

Obagi Medical Products, a division of

During the early weeks of therapy, an apparent ©OMP, Inc.

IF YOU HAVE QUESTIONS

exacerbation of inflammatory lesions may occur. This is www.obagi.com
due to the action of the medication on deep, previously

following instructions carefully. Should the

Valeant Pharmaceuticals International, Inc.

unseen lesions and should not be considered a reason to Rev. 03/2017

Valeant Pharmaceuticals North America LLC

These reactions can usually be minimized by
9441001 20000283B
There may be some discomfort or peeling

discontinue therapy.

improvement. Don’t stop treatment at the first

Don’t be discouraged if you see no immediate
an appearance of new blemishes (papules and

Once your acne is under control you should

These reactions do not happen to everyone.

If tretinoin is going to have a beneficial effect

pustules). At this stage it is important to continue
effects become excessively troublesome, consult
If they do, it is just your skin adjusting to tretinoin

continue regular application of tretinoin until your

All questions of a medical nature should be taken

during the early days of treatment. Some patients

BY THREE TO SIX WEEKS, some patients notice

in your appearance after 6 to 12 weeks of therapy.

and this usually subsides within two to four weeks.
also notice that their skin begins to take on a blush.

for you, you should notice a continued improvement