INDICATION AND IMPORTANT SAFETY INFORMATION FOR ALTRENO™ (TRETINOIN 0.05%) LOTION

Altreno is a trademark of Ortho Dermatologics’ affiliated entities. © 2018 All Rights Reserved. ALT.0043.USA.19


CONSUMER

WHAT IS ALTRENO™?

ALTRENO (tretinoin) lotion, 0.05% is a prescription medicine used on the skin (topical) to treat people with acne (blackheads, whiteheads, and other pimples).

IMPORTANT SAFETY INFORMATION

It is not known if ALTRENO is safe and effective in children under 9 years of age.
ALTRENO is for use on the skin only. Do not use it in your eyes, mouth, or vagina.

What should I tell my healthcare provider before using ALTRENO?

Before you use ALTRENO, tell your healthcare provider about all of your medical conditions, including if you:
- are allergic to fish. ALTRENO contains fish proteins. Tell your healthcare provider if you get hives or itching during treatment with ALTRENO.
- have eczema or any other skin problems.
- have a sunburn.
- are pregnant or plan to become pregnant. It is not known if ALTRENO will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if ALTRENO passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines, vitamins, or supplements may make your skin more sensitive to sunlight. Tell your healthcare provider about any cosmetics you use, including moisturizers, creams, lotions, or products that can dry out your skin.

What should I avoid while using ALTRENO?
  • You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with ALTRENO.
  • Minimize exposure to sunlight. If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with an SPF of 15 or more and wear protective clothing and a wide-brimmed hat to cover the treated areas.
What are the possible side effects of ALTRENO?


ALTRENO may cause serious side effects, including:

Skin Irritation: ALTRENO may cause irritation, including skin dryness, pain, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to stop using ALTRENO for a while, decrease how often you use it, or stop it altogether. Avoid applying ALTRENO to skin that is affected by eczema or sunburned.

  • You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with ALTRENO.
  • Minimize exposure to sunlight. If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with an SPF of 15 or more and wear protective clothing and a wide-brimmed hat to cover the treated areas.


You are encouraged to report negative side effects of prescription drugs. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

ALT.0023.USA.18

10/2018

Signature Page for ALT.0023.USA.18 v2.0


Trademark Approval Karen Tyler (Karen.Tyler@bauschhealth.com) on behalf of Holly Smith
Trademark
11-Oct-2018 13:15:53 GMT+0000
Medical Approval Eric Guenin
Medical
11-Oct-2018 13:42:08 GMT+0000
Regulatory Approval Barbara Thompson
Regulatory
11-Oct-2018 14:12:21 GMT+0000
Legal Approval Michael Dickey
Legal
11-Oct-2018 15:08:02 GMT+0000
Project Manager Approval Tanya Bowstead
Project Manager
11-Oct-2018 17:36:20 GMT+0000

Signature Page for ALT.0023.USA.18 v2.0


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