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.

TOLAK (NDA-022259)

(FLUOROURACIL)

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

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08/25/2022 (SUPPL-8)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Application Site Adverse Reactions

Additions and/or revisions underlined

…

Do not apply Tolak Cream directly into eyes, nose, mouth, or other mucous membranes because irritation, local inflammation and ulceration may occur. Avoid applying Tolak Cream on the eyelids. Tolak Cream is not indicated for use on eyes, eyelids, nose, mouth, or mucous membranes.

…

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined

…

Skin and subcutaneous tissue disorders: blistering, allergic contact dermatitis, photosensitivity, crusting, pain, scarring, skin irritation, rash, ulceration, erythema, burning, hyperpigmentation, alopecia, bullous pemphigoid, ichthyosis, scaling, suppuration, swelling, soreness, telangiectasia, tenderness, urticaria

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined

…

Important Administration Instructions

Tolak Cream is for external use only.
Do not apply to eyes, nose, mouth or mucous membranes.
Advise patients to avoid inadvertent transfer of Tolak Cream to other body areas, or to another person.
Keep out of the reach of children.
Fluorouracil, including Tolak may be fatal if ingested by pets. Avoid allowing pets to contact the Tolak container or the skin where Tolak has been applied. Store Tolak out of reach of pets. Safety discard or clean any cloth or applicator that may retain Tolak and avoid leaving any residues of Tolak on your hands, clothing, carpeting or furniture.
PATIENT INFORMATION
Additions and/or revisions underlined
…
What should I avoid while using Tolak Cream?
…

Do not breast feed or become pregnant while using Tolak. If you do become pregnant, stop using Tolak and tell your doctor right away.
Tolak may be fatal to your pet if your pet licks or ingests Tolak.
- Avoid allowing pets to contact the Tolak container or your skin where you applied Tolak.
- Store Tolak out of reach of pets.
- Safely discard or clean any cloth or applicator that may have Tolak residue.
- Avoid applying Tolak on your clothing, carpeting, or furniture.
  If your pet starts vomiting or starts having a seizure after your pet licks or ingests Tolak, seek immediate veterinary care for your pet.
  …