Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

RETIN-A MICRO (NDA-020475)

(TRETINOIN)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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09/10/2025 (SUPPL-29)

Approved Drug Label (PDF)

5 Warnings and Precautions

Additions and/or revisions underlined:

5.1 Local Skin Irritation

RETIN-A MICRO can cause local skin irritation, including excessive dryness, redness, swelling, peeling, itching, blistering, burning, or stinging [see Adverse Reactions (6.1)]. Use of RETIN-A MICRO in greater than the recommended dosage (more frequent than once daily application or excessive application) will not result in more rapid or improved acne results and may result in marked redness, peeling, or discomfort.

Tretinoin has been reported to cause severe local skin irritation on eczematous skin.

Weather extremes, such as severe wind or cold, may increase the risk of skin irritation in patients using RETIN- A MICRO.

To reduce the risk of local skin irritation, instruct RETIN-A MICRO-treated patients to:

Avoid use of RETIN-A MICRO in areas affected by eczema.
Minimize or avoid use of RETIN-A MICRO with weather extremes.
Wash the treated skin gently, using a mild, non-medicated soap, pat it dry, and avoid washing the treated skin too often or scrubbing it hard when washing. RETIN-A MICRO is not recommended with concomitant use of medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, spices, or lime peels.
Apply a topical moisturizer.

Advise patients that concomitant use of topical over the counter (OTC) acne products containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with RETIN-A MICRO may increase the risk for local skin irritation including dryness, erythema, and peeling. Consider withholding the use of topical OTC acne products if signs of skin irritation develop. Advise patients to allow the skin irritation effects of the topical OTC acne products to subside before initiation of RETIN-A MICRO treatment.

If severe local skin irritation occurs, discontinue RETIN-A MICRO use temporarily or permanently .

Efficacy of RETIN-A MICRO at reduced frequencies of application has not been established.

5.2 Initial Worsening of Inflammatory Acne Vulgaris

During the early weeks of RETIN-A MICRO treatment, an apparent exacerbation of inflammatory acne vulgaris lesions may occur. If RETIN-A MICRO is tolerated, initial worsening of inflammatory acne vulgaris lesions should not be considered a reason to discontinue therapy.

5.3 Photosensitivity

RETIN-A MICRO can cause photosensitivity. Advise patients to avoid or minimize unnecessary exposure to ultraviolet (UV) light, including sunlight and sunlamps, while using RETIN-A MICRO. Advise patients with sunburn to not use RETIN-A MICRO until the sunburn fully recovers.

Advise patients, especially those who may be required to have extended periods of UV light exposure (e.g., due to occupation or sports), those with inherent sensitivity to the sun, or those using drugs that cause photosensitivity, to use sun protection daily in the form of sunscreen (sun protection factor [SPF] greater than or equal to 15) and sun- protective clothing, when UV exposure cannot be avoided, even on days when it is not sunny or inside activities are expected.

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

RETIN-A MICRO, 0.1%

The safety of RETIN-A MICRO, 0.1% for the treatment of acne vulgaris was evaluated in two multicenter, double-blind, randomized, vehicle-controlled clinical trials (Studies 1 and 2). A total of 347 subjects with acne vulgaris were treated in Studies 1 and 2 in which 172 subjects received RETIN-A MICRO, 0.1% and 175 subjects received vehicle, applied topically once daily in the evening, for 12 weeks. Mean age was 19 years (range 11-40) and 55% were female [see Clinical Studies (14.1]. RETIN-A MICRO is not approved for use in pediatric patients younger than 12 years of age [see Indications and Usage (1)].

In Studies 1 and 2, subjects treated with RETIN-A MICRO, 0.1% had increased cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching that peaked during the initial two weeks of therapy and decreased thereafter, compared to those treated with vehicle [see Warnings and Precautions (5.1)]. During the 12-week treatment period, no more than 3% of RETIN-A MICRO, 0.1%-treated subjects had cutaneous irritation scores indicative of severe cutaneous irritation and 6% (14/224) of RETIN-A MICRO 0.1%-treated subjects discontinued treatment due to cutaneous irritation. Of these 14 subjects, four had severe cutaneous irritation after 3 to 5 days of treatment, with blistering in one subject.

RETIN-A MICRO, 0.04%

The safety of RETIN-A MICRO, 0.04% for the treatment of acne vulgaris was evaluated in two multicenter, double-blind, randomized, vehicle-controlled clinical trials (Studies 3 and 4). A total of 451 subjects with acne vulgaris were treated in Studies 3 and 4 in which 225 subjects received RETIN-A MICRO, 0.04% and 226 subjects received vehicle, applied once daily in the evening, for 12 weeks. Mean age was 19 years (range 11-49) and 57% were female [see Clinical Studies (14.2)]. RETIN-A MICRO is not approved for use in pediatric patients younger than 12 years of age [see Indications and Usage (1)].

In Studies 3 and 4, subjects treated with RETIN-A MICRO, 0.04% had increased cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching that peaked during the initial two weeks of therapy and decreased thereafter, compared to those treated with vehicle [see Warnings and Precautions (5.1)].

Approximately half of the 225 subjects in the RETIN-A MICRO, 0.04%-treated group had cutaneous irritation at Week 2. Of the subjects who experienced cutaneous irritation, most had signs or symptoms that were mild in severity (severity was ranked on a 4-point ordinal scale: 0=none, 1=mild, 2=moderate, and 3=severe). Less than 10% of RETIN-A MICRO, 0.04%-treated subjects experienced moderate cutaneous irritation, and none had severe cutaneous irritation at Week 2.

In Studies 3 and 4, during the 12-week treatment period, the majority of RETIN-A MICRO, 0.04%-treated subjects experienced cutaneous irritation (mild, moderate, or severe), of which, 1% (2/225) of subjects had cutaneous irritation scores indicative of a severe irritation and 1.3% (3/225) of subjects discontinued treatment due to cutaneous irritation, which included dryness in one subject and peeling and urticaria in another.

RETIN-A MICRO, 0.04% and 0.1%

In a double-blind trial, 156 subjects with acne vulgaris were treated for 12-weeks with RETIN-A MICRO 0.04% (n=78) or 0.1% (n=78) topically once daily. In this trial, the most frequently reported adverse events affected the skin and subcutaneous tissue (15% in the 0.04% group, and 21% in the 0.1% group). The most prevalent events in the 0.04% group were skin irritation (6%); and in the 0.1% group, skin burning (8%), erythema (5%), skin irritation (4%), and dermatitis (4%). In this trial, 63% of the adverse events were of mild intensity, and 34% were of moderate intensity.

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during post-approval use of RETIN-A MICRO and other topical tretinoin products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

Hyper- or hypopigmentation has been reported with repeated application of tretinoin.

8 Use in Specific Populations

8.1 Pregnancy

PLLR Conversion; please refer to label for complete information.

8.2 Lactation

PLLR Conversion: please refer to label for complete information.

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of RETIN-A MICRO for topical application for the treatment of acne vulgaris have been established in pediatric patients aged 12 years and older [see Clinical Studies (14)]. The safety and effectiveness of RETIN-A MICRO have not been established in pediatric patients younger than 12 years of age.

8.5 Geriatric Use

Additions and/or revisions underlined:

Clinical trials of RETIN-A MICRO did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger adult subjects. Acne vulgaris is largely a disease of pediatric and young adult patients. Clinical studies of RETIN-A MICRO did not include patients 65 years of age and older.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Administration

Instruct the patient to [see Dosage and Administration (2)]:

Thoroughly cleanse treatment area(s) with a mild, non-medicated cleanser then pat the skin dry prior to application of RETIN-A MICRO.
Avoid contact with eyes, mouth, paranal creases of nose, and mucous membranes when applying RETIN-A MICRO.
Apply a thin layer of RETIN-MICRO to cover the affected area(s).

Local Skin Irritation:

Advise the patient that use of RETIN-A MICRO greater than the recommended dosage will not result in more rapid of improved acne results and may result in marked redness, peeling or discomfort [see Warnings and Precautions (5.1)].

To reduce the risk of local skin irritation, advise the patient to:

Minimize or avoid use of RETIN-A MICRO during weather extremes, such as severe wind or cold.
Wash the treated skin gently, using a mild, non-medicated soap, and pat it dry, and avoid washing the treated skin too often or scrubbing it hard when washing.
Not use medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, spices, and lime peels while using RETIN-A MICRO.
Apply a topical moisturizer when using RETIN-A MICRO.

Advise the patient that concomitant use of topical OTC acne products containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with RETIN-A MICRO may increase the risk of local skin irritation. Advise the patient to withhold the use of topical OTC acne products if signs of skin irritation develop. Advise the patient to allow the skin irritation effects of the topical OTC acne products to subside before initiation of RETIN-A MICRO [see Warning and Precautions (5.1)].

Photosensitivity

Advise the patient to avoid or minimize unnecessary exposure to ultraviolet (UV) light, including sunlight and sunlamps, while using RETIN-A MICRO.

Advise the patient to not use RETIN-A MICRO on sunburn skin.

Advise the patient to use sun protection in the form of sunscreen (SPF greater than or equal to 15) and sun-protective clothing if UV exposure cannot be avoided [see Warnings and Precautions (5.3)].

Lactation

Advise the female patient to use RETIN-A MICRO on the smallest area of skin with acne vulgaris and for the shortest duration possible while breastfeeding. To avoid direct infant exposure, instruct the patient who is breastfeeding not to apply RETIN-A MICRO directly to the nipple and areola [see Use in Specific Populations (8.2)].

PATIENT INFORMATION

Additions and/or revisions underlined:

Important information: RETIN-A MICRO is for use on skin (topical use) only. Keep RETIN-A-MICRO away from your eyes, mouth, vagina, or the corners of your nose.

What is RETIN-A MICRO?

RETIN-A MICRO is a prescription medicine used on the skin (topical) to treat acne in adults and children 12 years of age and older. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples.

It is not known if RETIN-A MICRO is safe and effective in children under 12 years of age.

Before using RETIN-A MICRO, tell your healthcare provider about all of your medical conditions, including if you:

. . .

are breastfeeding or plan to breastfeed. It is not known if RETIN-A MICRO passes into your breast milk. If you breastfeed during treatment with RETIN-A MICRO, use RETIN-A MICRO on the smallest area of the skin with acne and for the shortest time possible. Do not apply RETIN-A MICRO directly to the nipple and areola to avoid contact with your baby.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you use any skin products that contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Using these topical skin products may increase the irritation of your skin when used with RETIN-A MICRO.

How should I use RETIN-A MICRO?

Use RETIN-A MICRO exactly as your healthcare provider tells you to use it.
Before you apply RETIN-A MICRO, gently wash the affected skin area with a mild, non-medicated soap. Rinse and pat your skin dry.
Apply a thin layer of RETIN-A MICRO to the affected area 1 time a day in the evening.
Do not use more RETIN-A MICRO than you need to cover the affected area and do not apply RETIN-A MICRO more than 1 time a day. Using too much RETIN-A MICRO or using it too often will not give you faster or better results, and you may get skin redness, peeling, or discomfort.
You may use moisturizers after applying RETIN-A MICRO.
Early in your treatment, you may get new pimples. At this stage, it is important to continue using RETIN-A MICRO.
Your acne may not get better right away. Improvement in your acne may be noticed after 2 weeks of RETIN-A MICRO treatment, but more than 7 weeks of treatment may be needed before you get the full benefit.

Wash your hands after applying RETIN-A MICRO.

RETIN-A MICRO taken by mouth in large amounts may lead to the same side effects as those seen with large amounts of Vitamin A taken by mouth. Call the Poison Help line at 1-800-222-1222 if RETIN-A MICRO is taken by mouth.

What should I avoid while using RETIN-A MICRO?

. . .

If you have to be in the sunlight, are sensitive to sunlight, or are using medicine that cause sensitive to sunlight, use a sunscreen with sun protection factor (SPF) of 15 or more. Wear a wide-brimmed hat or other protective clothing to cover the treated areas, even on days when it is not sunny, or you are inside.

Do not use RETIN-A MICRO on sunburn skin until your skin has healed

What are the possible side effects of RETIN-A MICRO? RETIN-A MICRO can cause serious side effects, including:

Skin irritation. RETIN-A MICRO can cause skin dryness, redness, swelling, peeling, itching, blistering, burning, or stinging. If you develop these symptoms, your healthcare provider may temporarily stop or completely stop your treatment with RETIN-A MICRO.

To help reduce the risk of skin irritation with RETIN-A MICRO:

Avoid use of RETIN-A MICRO in skin areas affected by eczema.

Minimize or avoid use of RETIN-A MICRO with weather extremes, such as severe wind or cold.

Avoid washing the treated skin too often or scrubbing it hard when washing. RETIN-A MICRO is not recommended with use of medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high amounts of alcohol, astringents, spices, or lime peels.
Apply a topical moisturizer when using RETIN-A MICRO.

It is not known if RETIN-A MICRO is effective when used less than 1 time a day.

Sensitivity to sunlight. See “What should I avoid while using RETIN-A MICRO?”

The most common side effects of RETIN-A MICRO include skin redness, pain, and itching. 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 possible side effects of RETIN-A MICRO.

. . .