Tretinoin (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

Tretinoin Gel, 0.05% is a translucent to opaque, pale yellow topical gel and available as:

20 g tubes (NDC 62032-413-20)

Storage and Handling: Store at controlled room temperature 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Protect from freezing. Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Patient Information)

Instruct patients to clean the affected areas with an appropriate cleanser before applying Tretinoin Gel.

Patients may use moisturizers that are noncomedogenic and should avoid products that could be drying or irritating.

Patients may also wear cosmetics while being treated with Tretinoin Gel; however, they should be instructed to remove the cosmetics and clean the area thoroughly before applying Tretinoin Gel.

Warn patients of the drying and irritation effects often seen during treatment. Continue use of the medication if these effects are tolerable.

Caution patients against application of Tretinoin Gel around the eyes, mouth, paranasal creases, and mucous membranes as the skin is especially prone to irritation.

Minimize exposure to sunlight, including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided.

Rx only

Distributed by:
Obagi Cosmeceuticals LLC
Long Beach, CA 90806

All products/brand names, whether designated by notice or not (®/TM), are trademarks of Obagi Cosmeceuticals LLC and/or its affiliates.

©2021 Obagi Cosmeceuticals LLC. All rights reserved. www.obagi.com
9376703

Patient Package Insert

Patient Information
Tretinoin Gel, 0.05%
For topical use

Important information: Tretinoin Gel is for use on skin only. Do not get Tretinoin Gel in your mouth, eyes, vagina, or the corners of your nose.

What is Tretinoin Gel?

Tretinoin Gel is a prescription medicine used on the skin (topical) to treat acne. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples.

It is not known if Tretinoin Gel is safe and effective in children under 10 years of age.

What should I tell my healthcare provider before using Tretinoin Gel?

Before using Tretinoin Gel, tell your healthcare provider about all of your medical conditions, including if you:

are allergic to fish. Tretinoin Gel contains fish proteins. Tell your healthcare provider if you get hives or itching during treatment with Tretinoin Gel.
have a skin condition called eczema.
have a sunburn.
are pregnant or plan to become pregnant. It is not known if Tretinoin Gel will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if Tretinoin Gel passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and any skin products that you use.

Especially tell your healthcare provider if you use any other medicines to treat your acne, including medicated cleansers or soaps. Using other topical acne products may increase the irritation of your skin when used with Tretinoin Gel.

How should I use Tretinoin Gel?

Use Tretinoin Gel exactly as your healthcare provider tells you to use it.
Before you apply Tretinoin Gel, gently wash the affected skin area with a mild, non-medicated soap. Rinse and pat your skin dry.
Apply Tretinoin Gel 1 time a day before bedtime.
Apply a thin layer of Tretinoin Gel to cover the affected skin areas. Gently rub Tretinoin Gel into your skin.
Do not use more Tretinoin Gel than you need to cover the affected area and do not apply Tretinoin Gel more than 1 time a day. Using too much Tretinoin Gel may irritate or increase the irritation of your skin, and will not give faster or better results.
You may use moisturizers and cosmetics.

What should I avoid while using Tretinoin Gel?

Avoid washing your skin too often and scrubbing the affected skin area.
You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with Tretinoin Gel.
Minimize exposure to sunlight.
If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with a SPF (sun protection factor) of 15 or more and wear protective clothing, and a wide brimmed hat to cover the treated areas.
If you do get sunburned, stop using Tretinoin Gel until your skin has healed and is back to normal.
Cold weather and wind may irritate skin treated with Tretinoin Gel. Skin treated with Tretinoin Gel may dry out or get wind burned more easily. Talk to your healthcare provider about ways to manage skin irritation.
Avoid contact with the peels of limes.

What are the possible side effects of Tretinoin Gel?

Tretinoin Gel may cause skin irritation, including: skin dryness, burning, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to stop using Tretinoin Gel for a while, decrease the number of times you apply Tretinoin Gel, or completely stop treatment with Tretinoin Gel. It is not known if Tretinoin Gel is effective when used less than 1 time a day.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the side effects possible with Tretinoin Gel.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Tretinoin Gel?

Store Tretinoin Gel at room temperature, 68°F to 77°F (20°C to 25°C).
Protect from freezing.

Keep Tretinoin Gel and all medicines out of the reach of children.

General information about the safe and effective use of Tretinoin Gel

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tretinoin Gel for a condition for which it was not prescribed. Do not give Tretinoin Gel to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Tretinoin Gel that is written for health professionals.

What are the ingredients of Tretinoin Gel?

Active ingredient: tretinoin

Inactive ingredients: benzyl alcohol, butylparaben, butylated hydroxytoluene, carbomer homopolymer Type C, ethylparaben, fish collagen hydrolyzates, glycerin, isobutylparaben, methylparaben, octoxynol 9, phenoxyethanol, propylparaben, purified water, sodium hyaluronate, and trolamine.

Distributed by:
Obagi Cosmeceuticals LLC
Long Beach, CA 90806

All products/brand names, whether designated by notice or not (®/TM), are trademarks of Obagi Cosmeceuticals LLC and/or its affiliates.

©2021 Obagi Cosmeceuticals LLC. All rights reserved. www.obagi.com
This Patient Information has been approved by the U.S. Food and Drug Administration.
9376703
Rev. 05/2021

PRINCIPAL DISPLAY PANEL — 20 g Carton

NDC 62032-413-20

Rx only

Tretinoin Gel
USP 0.05%

OBAGI®
Medical

FOR TOPICAL USE ONLY Net Wt. 0.7 oz. (20 g)

carton
(click image for full-size original)
TRETINOIN tretinoin gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-413
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRETINOIN (TRETINOIN) TRETINOIN 0.05 g in 100 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
BUTYLPARABEN
BUTYLATED HYDROXYTOLUENE
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
ETHYLPARABEN
MARINE COLLAGEN, SOLUBLE
GLYCERIN
ISOBUTYLPARABEN
METHYLPARABEN
OCTOXYNOL-9
PHENOXYETHANOL
PROPYLPARABEN
WATER
HYALURONATE SODIUM
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-413-20 20 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022070 06/19/2014
Labeler — Obagi Cosmeceuticals LLC (790553353)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd. 832224526 MANUFACTURE (62032-413)
Establishment
Name Address ID/FEI Operations
Bausch Health Companies Inc. 245141858 MANUFACTURE (62032-413)

Revised: 05/2021 Obagi Cosmeceuticals LLC

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