Retin-A

Retin-A is available in a variety of strengths, ranging from 0.01 to 0.1 percent, and a variety of forms, such as creams, gels, and solutions.

No matter which form you're using, it's best to apply a pea-sized amount to the affected areas each night after you wash your skin.

Don't expect to notice the difference right away since it might take weeks or months before you see any visible improvements.

Use Retin-A gel, cream, or liquid once a day to the affected area on your skin before going to bed.

If you are using the liquid, apply it with your fingertip, a gauze pad or cotton swab. Don't let the liquid run into non-affected areas.

Use Retin-A exactly as prescribed. Don't use it longer than you are supposed to or increase the frequency or amount. This won't make it work faster, but it could lead to more side effects.

Before applying Retin-A, wash and dry the area you plan to treat and wash your hands before and after you apply it.

Don't wash the treated area again or use other skin products on the treated area for at least one hour after Retin-A is applied.

Retin-A Overdose

Retin-A is not likely to cause overdose symptoms, but if you think you have applied too much get emergency medical attention right away.

Missed Dose of Retin-A

Never use extra medication to make up for a missed dose.

If you forget to use Retin-A, put it on as soon as you remember unless it's almost time for the next dose.

If that is the case, then skip the missed dose and resume your regular schedule.

The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of RETIN-A. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with RETIN-A. To date, all adverse effects of RETIN-A have been reversible upon discontinuance of therapy (see DOSAGE AND ADMINISTRATION Section).

• Ortho-McNeil Janssen Pharmaceuticals, Inc.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• thiazide diuretics
• tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Monodox, Vibramycin, others), minocycline (Minocin), oxytetracycline (Terramycin), and tetracycline (Sumycin, Tetrex, others)
• fluoroquinolone antibiotics
• ketoconazole (Nizoral)
• phenothiazine medications
• sulfonamide-containing medications
• aminocaproic acid (Amicar)
• certain calcium channel blockers such as diltiazem (Cardizem, Dilacor, Tiazac, others) and verapamil (Calan, Covera, Isoptin, Verelan)
• cimetidine (Tagamet)
• cyclosporine (Sandimmune, Gengraf, Neoral)
• erythromycin (E.E.S., Erythrocin, E-Mycin)
• hydroxyurea (Droxia)
• pentobarbital
• phenobarbital
• rifampin (Rifadin, Rimactane)
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)
• tranexamic acid (Cyklokapron)
• vitamin A

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

You should avoid using skin products that can dry or irritate your skin because skin dryness and irritation are increased with Retin-A. Skin products that can dry and irritate your skin include:

• products that contain alcohol, astringents, or spices
• acne medicines that contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid
• medicated soap or skin cleansers

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

• Retin-A: store below 80˚F

Avoid exposure to sunlight or tanning beds. Tretinoin topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors, even on a cloudy day.

Avoid getting this medication in your eyes, nose, mouth, or in the creases of your nose.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Avoid using other medications on the areas you treat with tretinoin topical unless your doctor tells you to.

Do not use skin products that contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid unless otherwise directed by your doctor. These products can cause severe skin irritation if used with tretinoin topical.

It is not likely that other drugs you take orally or inject will have an effect on topically applied tretinoin. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of Retin-A. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with Retin-A. To date, all adverse effects of Retin-A have been reversible upon discontinuance of therapy (see Dosage and Administration).

Retin-A Gel or Cream should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Gel: Excessive application results in "pilling" of the gel, which minimizes the likelihood of over application by the patient.

Application may cause a transitory feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment.

Alterations of vehicle, drug concentration, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance.

During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy.

Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen.

Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications, or other dosage forms.

Patients treated with Retin-A (tretinoin) acne treatment may use cosmetics, but the area to be treated should be cleansed thoroughly before the medication is applied. (seePrecautions.)

NDC 0187-5160-20

Retin-A® Cream
(tretinoin) 0.025%

Each gram contains: Tretinoin 0.025%, stearic acid, isopropyl
myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated
hydroxytoluene, and purified water.

For Topical Use Only   
Rx only
Usual Dosage: See package insert.
Store below 80°F.
WARNING: Keep out of reach of children.

Net Wt. 20 g

NDC 0187-5162-20

Retin-A® Cream
(tretinoin) 0.05%

Each gram contains: Tretinoin 0.05%, stearic acid,
isopropyl myristate, polyoxyl 40 stearate, stearyl
alcohol, xanthan gum, sorbic acid, butylated
hydroxytoluene, and purified water.

For Topical Use Only   
Rx only
Usual Dosage: See package insert.
Store below 80°F.
WARNING: Keep out of reach of children.

Net Wt. 20 g

NDC 0187-5170-45

Retin-A® Gel
(tretinoin) 0.025%

Each gram contains: Tretinoin 0.025%, butylated hydroxytoluene,
hydroxypropyl cellulose and alcohol (denatured with tert-butyl
alcohol and brucine sulfate) 90% w/w.

For Topical Use Only   
Rx only
Usual Dosage: See package insert.
Store below 86°F.
WARNING: Keep out of reach of children.

Net Wt. 45 g

Avoid exposure to sunlight or tanning beds. Retin-A can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors, even on a cloudy day.

Avoid getting this medication in your eyes, nose, mouth, or in the creases of your nose.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Avoid using other medications on the areas you treat with Retin-A unless your doctor tells you to.

More frequent side effects include: exfoliation of skin, stinging of the skin, localized warm feeling, and mild erythema. See below for a comprehensive list of adverse effects.