Fluorouracil 5 mg/g Cream — NDC 75907-169-11 (Billing 75907-0169-11)
This is a package of Fluorouracil 5 mg/g Cream from Dr. Reddy's Laboratories Inc., marketed since Jul 2025 and currently FDA-listed; retail pharmacies pay about $42.88 per g (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 75907-169-11 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 75907 labeler · 169 product · 11 package
- Package marketed since
- Jul 6, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 7590716911 3
- Medicaid fills, this package
- 181 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 047443
- GCN: 12514
- GPI-14 (Medi-Span): 90372030003705
- HICL (First Databank): 003907
- AHFS class code: 10:00.00.00
- RxCUI (RxNorm): 284191
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Nucleoside Metabolic Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the form. By IV, it treats colon, rectal, breast, stomach and pancreatic cancers. As a skin cream or solution, it treats actinic keratosis (sun-damaged patches) and,...
- Follow your label and prescriber. Tolak is applied once daily after washing and drying the area. The 5% cream and solution are applied twice daily. Use a nonmetal applicator or glo...
- How do I use the skin cream or solution?
- Redness, dryness, scaling, crusting, itching, stinging or burning, swelling and raw spots are very common. They usually peak at the end of treatment and fade within about 4 weeks a...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $42.876 | $1,286.27 / 30 g |
| Medicaid paysCMS SDUD · 12 mo | $47.30 | $1,419.01 / 30 g |
| Medicare drug plans payPart D · Q2 2026 | $46.33 | $1,389.89 / 30 g |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 75907-0169-11 You're viewing this Main listing | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | 2025-07-06 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fluorouracil 5 mg/gthis 75907-0169-11 | Dr. | 1 tube | $42.876 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Dr. Reddy's Laboratories Inc. labeler code 75907
- PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL Solution/ Drops NDC 75907-129-07
- PHENYLEPHRINE HYDROCHLORIDE 100 mg/mL Solution/ Drops NDC 75907-130-23
- Omeprazole and Sodium Bicarbonate 20 mg; 1680 mg Powder, For Suspension NDC 75907-138-42
- Dual Action Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/ 125 mg 125 mg; 250 mg Tablet, Film Coated NDC 75907-158-14
- Metyrosine 250 mg Capsule NDC 75907-166-01
- Ivermectin 3 mg Tablet NDC 75907-167-21
- CYCLOPHOSPHAMIDE 200 mg/mL Injection, Solution NDC 75907-189-35
- CYCLOPHOSPHAMIDE 200 mg/mL Injection, Solution NDC 75907-190-07
- CYCLOPHOSPHAMIDE 200 mg/mL Injection, Solution NDC 75907-191-02
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide 2 mg/5mL; 10 mg/5mL; 30 mg/5mL Syrup NDC 75907-207-04
- Calcium Chloride 100 mg/mL Injection, Solution NDC 75907-223-10
- Abiraterone Acetate 250 mg Tablet NDC 75907-224-04
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Fluorouracil cream, 0.5% is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Fluorouracil cream, 0.5% should be applied once a day to the skin where actinic keratosis lesions appear, using enough to cover the entire area with a thin film. Fluorouracil cream, 0.5% should not be applied near the eyes, nostrils, or mouth. Fluorouracil cream, 0.5% should be applied 10 minutes after thoroughly washing, rinsing, and drying the entire area.
Fluorouracil cream, 0.5% may be applied using the fingertips. Immediately after application, the hands should be thoroughly washed. Fluorouracil cream, 0.5% should be applied up to 4 weeks as tolerated.
Continued treatment up to 4 weeks results in greater lesion reduction. Local irritation is not markedly increased by extending treatment from 2 to 4 weeks, and is generally resolved within 2 weeks of cessation of treatment.
⛔ Contraindications ▾
CONTRAINDICATIONS Fluorouracil may cause fetal harm when administered to a pregnant woman. Fluorouracil is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
No adequate and well-controlled studies have been conducted in pregnant women with either topical or parenteral forms of fluorouracil. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when fluorouracil was applied to mucous membrane areas. Multiple birth defects have been reported in the fetus of a patient treated with intravenous fluorouracil.
Animal reproduction studies have not been conducted with fluorouracil cream, 0.5%. Fluorouracil, the active ingredient, has been shown to be teratogenic in mice, rats, and hamsters when administered parenterally at doses greater than or equal to 10, 15, and 33 mg/kg/day, respectively, [4X, 11X and 20X, respectively, the Maximum Recommended Human Dose (MRHD) based on body surface area (BSA)]. Fluorouracil was administered during the period of organogenesis for each species.
Embryolethal effects occurred in monkeys at parenteral doses greater than 40 mg/kg/day (65X the MRHD based on BSA) administered during the period of organogenesis. Fluorouracil cream, 0.5% should not be used in patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. A large percentage of fluorouracil is catabolized by the DPD enzyme.
DPD enzyme deficiency can result in shunting of fluorouracil to the anabolic pathway, leading to cytotoxic activity and potential toxicities. Fluorouracil cream, 0.5% is contraindicated in patients with known hypersensitivity to any of its components.
⚠️ Warnings ▾
WARNINGS The potential for a delayed hypersensitivity reaction to fluorouracil exists. Patch testing to prove hypersensitivity may be inconclusive. Patients should discontinue therapy with fluorouracil cream, 0.5% if symptoms of DPD enzyme deficiency develop.
Rarely, unexpected systemic toxicity (e.g., stomatitis, diarrhea, neutropenia, neurotoxicity) associated with parenteral administration of fluorouracil has been attributed to deficiency of dihydropyrimidine dehydrogenase “DPD” activity. One case of life-threatening systemic toxicity has been reported with the topical use of 5% fluorouracil in a patient with a complete absence of DPD enzyme activity. Symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, and chills.
Physical examination revealed stomatitis, erythematous skin rash, neutropenia, thrombocytopenia, inflammation of the esophagus, stomach, and small bowel. Although this case was observed with 5% fluorouracil cream, it is unknown whether patients with profound DPD enzyme deficiency would develop systemic toxicity with lower concentrations of topically applied fluorouracil. Applications to mucous membranes should be avoided due to the possibility of local inflammation and ulceration.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following were adverse events considered to be drug related and occurring with a frequency of 1% with fluorouracil cream, 0.5%: application site reaction (94.6%), and eye irritation (5.4%). The signs and symptoms of facial irritation (i.e., application site reaction) are presented below. Summary of Facial Irritation Signs and Symptoms - Pooled Phase 3 Studies Clinical Sign or Symptom Active 1 Week N=85 Active 2 Week N=87 Active 4 Week N=85 ALL Active Treatments N=257 Vehicle Treatments N=127 n (%) n (%) n (%) n (%) n (%) Erythema 76 (89.4) 82 (94.3) 82 (96.5) 240 (93.4) 76 (59.8) Dryness 59 (69.4) 76 (87.4) 79 (92.9) 214 (83.3) 60 (47.2) Burning 51 (60.0) 70 (80.5) 71 (83.5) 192 (74.7) 28 (22.0) Erosion 21 (24.7) 38 (43.7) 54 (63.5) 113 (44.0) 17 (13.4) Pain 26 (30.6) 34 (39.1) 52 (61.2) 112 (43.6) 7 (5.5) Edema 12 (14.1) 28 (32.2) 51 (60.0) 91 (35.4) 6 (4.7) During clinical trials, irritation generally began on Day 4 and persisted for the remainder of treatment.
Severity of facial irritation at the last treatment visit was slightly below baseline for the vehicle group, mild to moderate for the 1-week active treatment group, and moderate for the 2- and 4-week active treatment groups. Mean severity declined rapidly for each active group after completion of treatment and was below baseline for each group at the Week 2 post-treatment follow-up visit. Thirty-one patients (12% of those treated with fluorouracil cream, 0.5% in the Phase 3 clinical studies) discontinued study treatment early due to facial irritation.
Except for three patients, discontinuation of treatment occurred on or after Day 11 of treatment. Eye irritation adverse events, described as mild to moderate in intensity, were characterized as burning, watering, sensitivity, stinging, and itching. These adverse events occurred across all treatment arms in one of the two Phase 3 studies.
Summary of All Adverse Events Reported in ≥ 1% of Patients in the Combined Active Treatment and Vehicle Groups – Pooled Phase 3 Studies 9721 and 9722 Combined Adverse Event Active 1 Week N=85 Active 2 Week N=87 Active 4 Week N=85 ALL Active Treatments N=257 Vehicle Treatments N=127 n (%) n (%) n (%) n (%) n (%) BODY AS A WHOLE Headache Allergy Infection Upper Respiratory 7 (8.2) 3 (3.5) 4 (4.7) 0 0 6 (6.9) 2 (2.3) 0 2 (2.3) 0 12 (14.1) 3 (3.5) 2 (2.4) 1 (1.2) 0 25 (9.7) 8 (3.1) 6 (2.3) 3 (1.2) 0 15 (11.8) 3 (2.4) 3 (2.4) 2 (1.6) 2 (1.6) MUSCULOSKELETAL Muscle Soreness 1 (1.2) 0 1 (1.1) 0 1 (1.2) 0 3 (1.2) 0 5 (3.9) 2 (1.6) RESPIRATORY Sinusitis 5 (5.9) 4 (4.7) 0 0 1 (1.2) 0 6 (2.3) 4 (1.6) 6 (4.7) 2 (1.6) SKIN & APPENDAGES Application site Reaction Irritation Skin 78 (91.8) 78 (91.8) 1 (1.2) 83 (95.4) 83 (95.4) 0 82 (96.5) 82 (96.5) 2 (2.4) 243 (94.6) 243 (94.6) 3 (1.2) 85 (66.9) 83 (65.4) 0 SPECIAL SENSES Eye Irritation 6 (7.1) 5 (5.9) 4 (4.6) 3 (3.4) 6 (7.1) 6 (7.1) 16 (6.2) 14 (5.4) 6 (4.7) 3 (2.4) Adverse Experiences Reported by Body System: In the Phase 3 studies, no serious adverse event was considered related to study drug.
A total of five patients, three in the active treatment groups and two in the vehicle group, experienced at least one serious adverse event. Three patients died as a result of adverse event(s) considered unrelated to study drug (stomach cancer, myocardial infarction, and cardiac failure). Post-treatment clinical laboratory tests other than pregnancy tests were not performed during the Phase 3 clinical studies.
Clinical laboratory tests were performed during conduct of a Phase 2 study of 104 patients and 21 patients in a Phase 1 study. No abnormal serum chemistry, hematology, or urinalysis results in these studies were considered clinically significant. To report SUSPECTED ADVERSE EVENTS, contact Dr.
Reddy’s Laboratories Inc, at 1-888-375-3784 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.
🤰 Pregnancy ▾
Pregnancy See CONTRAINDICATIONS.
🧒 Pediatric Use ▾
Pediatric Use Actinic keratosis is not a condition seen within the pediatric population, except in association with rare genetic diseases. Fluorouracil cream, 0.5% should not be used in children. The safety and effectiveness of fluorouracil cream, 0.5% have not been established in patients less than 18 years old.
🧓 Geriatric Use ▾
Geriatric Use No significant differences in safety and efficacy measures were demonstrated in patients age 65 and older compared to all other patients.
🆘 Overdosage ▾
OVERDOSE Ordinarily, topical overdosage will not cause acute problems. If Fluorouracil cream, 0.5% is accidentally ingested, induce emesis and gastric lavage. Administer symptomatic and supportive care as needed. If contact is made with the eye, flush with copious amounts of water.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY There is evidence that the metabolism of fluorouracil in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid. In this manner, fluorouracil interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA). Since DNA and RNA are essential for cell division and growth, the effect of fluorouracil may be to create a thymine deficiency that provokes unbalanced growth and death of the cell.
The effects of DNA and RNA deprivation are most marked on those cells that grow more rapidly and take up fluorouracil at a more rapid rate. The contribution to efficacy or safety of individual components of the vehicle has not been established. Pharmacokinetics: A multiple-dose, randomized, open-label, parallel study was performed in 21 patients with actinic keratoses.
Twenty patients had pharmacokinetic samples collected: 10 patients treated with fluorouracil cream, 0.5% and 10 treated with Efudex® 5% Cream. Patients were treated for a maximum of 28 days with Fluorouracil cream, 0.5%, 1 g once daily in the morning; or Efudex® 5% Cream, 1 g twice daily, in the morning and evening. Steady-state plasma concentrations and the amounts of fluorouracil in urine resulting from the topical application of either product were measured.
Three patients who received Fluorouracil cream, 0.5% and nine patients who received Efudex® 5% Cream had measurable plasma fluorouracil levels; however, only one patient receiving Fluorouracil cream, 0.5% and six patients receiving Efudex® 5% Cream had a sufficient number of data points to calculate mean pharmacokinetic parameters. Plasma Pharmacokinetic Summary PK Parameter Fluorouracil Cream, 0.5% n=1 Efudex® (Mean ± SD) n=6 C max 0.77 ng/mL 11.49 ± 8.24 ng/mL T max 1.00 hr 1.03 ± 0.028 hr AUC (0-24) 2.80 ng•hr/mL 22.39 ± 7.89 ng•hr/mL Five of 10 patients receiving fluorouracil cream, 0.5% and nine of 10 patients receiving Efudex ® 5% Cream had measurable urine fluorouracil levels.
Urine Pharmacokinetic Summary PK Parameter Fluorouracil Cream, 0.5% (Mean ± SD) (Range) n=10 Efudex® (Mean ± SD) (Range) n=10 Cum Ae † (min-max) 2.74 ± 5.22 mcg (0-15.02) 119.83 ± 94.80 mcg (0-329.87) Max excretion rate (min-max) 0.19 ± 0.52 mcg/hr (0-1.67) 40.27 ± 47.14 mcg/hr (0-164.5) † Cumulative urinary excretion Both Fluorouracil cream, 0.5% and Efudex ® 5% Cream demonstrated low measurable plasma concentrations for fluorouracil when administered under steady-state conditions. Cumulative urinary excretion of fluorouracil was low for fluorouracil cream, 0.5% and for Efudex ® , corresponding to 0.055% and 0.24% of the applied doses, respectively.
Clinical Trials: Under the experimental conditions of the topical safety studies, fluorouracil cream, 0.5% was not observed to cause contact sensitization. However, approximately 95% of subjects in the active arms of the Phase 3 clinical studies experienced facial irritation. Irritation is likely and sensitization is unlikely based on the results of the topical safety and Phase 3 studies.
Two Phase 3 identically designed, multicenter, vehicle-controlled, double-blind studies were conducted to evaluate the clinical safety and efficacy of fluorouracil cream, 0.5%. Patients with five or more actinic keratoses (AKs) on the face or anterior bald scalp were randomly allocated to active or vehicle treatment in a 2:1 ratio. Patients were randomly allocated to treatment durations of 1, 2, or 4 weeks in a 1:1:1 ratio.
They applied the study cream once daily to the entire face/anterior bald scalp. Each patient’s clinical response was evaluated 4 weeks after the patient’s last scheduled application of study cream. No additional post-treatment follow-up efficacy or safety assessments were performed beyond 4 weeks after the last scheduled application.
The following graphs show the percentage of patients in whom 100% of treated lesions cleared, and the percentage of patients in whom 75… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Fluorouracil Cream, 0.5%, is a white to off-white cream, supplied as follows: NDC 75907-169-11: 30 g tube Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION Fluorouracil cream, 0.5%, contains fluorouracil for topical dermatologic use. Chemically, fluorouracil is 5-fluoro-2,4(1H, 3H)-pyrimidinedione. The molecular formula is C 4 H 3 FN 2 O 2 .
Fluorouracil has a molecular weight of 130.08. Fluorouracil cream contains 0.5% fluorouracil, with 0.35% being incorporated into a patented porous microsphere (Microsponge ® ) composed of methyl methacrylate/glycol dimethacrylate crosspolymer and dimethicone. The cream formulation contains the following other inactive ingredients: Carbomer Homopolymer Type C, glycerin, methyl gluceth-20, methylparaben, octyl hydroxy stearate, polyethylene glycol 400, polysorbate 80, propylene glycol, propylparaben, purified water, sorbitan monooleate, stearic acid, and trolamine. chemical-structure
💬 Information for Patients ▾
Information for the Patient Patients using fluorouracil cream, 0.5% should receive the following information and instructions: 1. This medication is to be used as directed. 2.
This medication should not be used for any disorder other than that for which it was prescribed. 3. It is for topical use only.
4. Avoid contact with the eyes, eyelids, nostrils, and mouth. 5.
Cleanse affected area and wait 10 minutes before applying fluorouracil cream, 0.5%. 6. Wash hands immediately after applying fluorouracil cream, 0.5%.
7. Avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment, as the intensity of the reaction may be increased. 8.
Most patients using fluorouracil cream, 0.5% get skin reactions where the medicine is used. These reactions include redness, dryness, burning, pain, erosion (loss of the upper layer of skin), and swelling. Irritation at the application site may persist for two or more weeks after therapy is discontinued.
Treated areas may be unsightly during and after therapy. 9. If you develop abdominal pain, bloody diarrhea, vomiting, fever, or chills while on fluorouracil cream, 0.5% therapy, stop the medication and contact your physician and/or pharmacist.
10. Report any side effects to the physician and/or pharmacist. 11.
Fluorouracil, including fluorouracil cream, 0.5% may be fatal if ingested by pets. Avoid allowing pets to contact the fluorouracil cream, 0.5% container or the skin where fluorouracil cream, 0.5% has been applied. Store fluorouracil cream, 0.5% out of reach of pets.
Safely discard or clean any cloth or applicator that may retain fluorouracil cream, 0.5% and avoid leaving any residues of fluorouracil cream, 0.5% on your hands, clothing, carpeting or furniture.
💬 Patient Medication Information ▾
PATIENT INFORMATION Fluorouracil Cream, 0.5% Read this leaflet carefully before you start to use your medicine. Read the information you get every time you get more medicine. There may be new information about the drug.
This leaflet does not take the place of talks with your doctor. If you have any questions or are not sure about something, ask your doctor or pharmacist. What is fluorouracil cream, 0.5%?
Fluorouracil cream, 0.5% is a cream used by adults to treat skin conditions on the face and front part of the scalp called solar keratosis or actinic keratosis. Who should not use fluorouracil cream, 0.5%? Do not use fluorouracil cream, 0.5%: if you are pregnant or might become pregnant.
Fluorouracil cream, 0.5% may harm your unborn child. if you are nursing a baby. We do not know if fluorouracil cream, 0.5% can pass to the baby through the milk. if you have dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. The active ingredient in fluorouracil cream, 0.5%, fluorouracil, can cause serious side effects in patients who are DPD enzyme deficient.
If you have DPD enzyme deficiency and use medications containing fluorouracil, you may develop serious side effects such as stomach pain, bloody diarrhea, vomiting, fever, or chills. if you are allergic to the ingredients in fluorouracil cream, 0.5%. Ask your doctor or pharmacist about the inactive ingredients. if you are under 18 years of age. Fluorouracil cream, 0.5% should not be used in children.
Tell your doctor if you are able to become pregnant. Your doctor may advise you about birth control to avoid pregnancy. How should I use fluorouracil cream, 0.5%?
Use fluorouracil cream, 0.5% once a day as instructed by your doctor. Use it only on your skin. You should use fluorouracil cream, 0.5% for up to 4 weeks.
1. Clean the area where you will apply fluorouracil cream, 0.5%. Rinse well and dry the area with a towel and wait 10 minutes before applying fluorouracil cream, 0.5%.
2. Put fluorouracil cream, 0.5% on your face as directed by your physician, using your fingertips. Use enough to cover the affected skin.
3. Avoid contact with your eyes, nostrils, and mouth. 4.
Wash your hands as soon as you finish putting fluorouracil cream, 0.5% on your skin. 5. A moisturizer/sunscreen may be applied 2 hours after fluorouracil cream, 0.5% has been applied.
Do not use any other skin products, including creams, lotions, medications, or cosmetics – unless instructed by your doctor. What should I avoid while using fluorouracil cream, 0.5%? Avoid sunlight or other ultraviolet light (such as tanning booths) as much as possible while using fluorouracil cream, 0.5%.
Sunlight may increase your side effects. When exposed to sunlight, wear a hat and use sunscreen. Do not cover the treated skin with a dressing.
Do not breast feed or become pregnant while using fluorouracil cream, 0.5%. If you do become pregnant, stop using fluorouracil cream, 0.5% and tell your doctor right away. Fluorouracil cream, 0.5% may be fatal to your pet if your pet licks or ingests fluorouracil cream, 0.5%.
Avoid allowing pets to contact the fluorouracil cream, 0.5% container or your skin where you applied fluorouracil cream, 0.5%. Store fluorouracil cream, 0.5% out of reach of pets. Safely discard or clean any cloth or applicator that may have fluorouracil cream, 0.5% residue.
Avoid applying fluorouracil cream, 0.5% on your clothing, carpeting, or furniture. If your pet starts vomiting or starts having a seizure after your pet licks or ingests fluorouracil cream, 0.5%, seek immediate veterinary care for your pet. What are the possible side effects of fluorouracil cream, 0.5%?
Most patients using fluorouracil cream, 0.5% get skin reactions where the medicine is used. These reactions include redness, dryness, burning, pain, erosion (loss of the upper layer of skin), and swelling. Irritation may continue for 2 or more weeks after treatment is over.
The treated area may become unsightly during therapy. Some patients get eye irri… [Excerpted — this section continues on DailyMed.]
⚠️ Precautions ▾
PRECAUTIONS General There is a possibility of increased absorption through ulcerated or inflamed skin. Information for the Patient Patients using fluorouracil cream, 0.5% should receive the following information and instructions: 1. This medication is to be used as directed.
2. This medication should not be used for any disorder other than that for which it was prescribed. 3.
It is for topical use only. 4. Avoid contact with the eyes, eyelids, nostrils, and mouth.
5. Cleanse affected area and wait 10 minutes before applying fluorouracil cream, 0.5%. 6.
Wash hands immediately after applying fluorouracil cream, 0.5%. 7. Avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment, as the intensity of the reaction may be increased.
8. Most patients using fluorouracil cream, 0.5% get skin reactions where the medicine is used. These reactions include redness, dryness, burning, pain, erosion (loss of the upper layer of skin), and swelling.
Irritation at the application site may persist for two or more weeks after therapy is discontinued. Treated areas may be unsightly during and after therapy. 9.
If you develop abdominal pain, bloody diarrhea, vomiting, fever, or chills while on fluorouracil cream, 0.5% therapy, stop the medication and contact your physician and/or pharmacist. 10. Report any side effects to the physician and/or pharmacist.
11. Fluorouracil, including fluorouracil cream, 0.5% may be fatal if ingested by pets. Avoid allowing pets to contact the fluorouracil cream, 0.5% container or the skin where fluorouracil cream, 0.5% has been applied.
Store fluorouracil cream, 0.5% out of reach of pets. Safely discard or clean any cloth or applicator that may retain fluorouracil cream, 0.5% and avoid leaving any residues of fluorouracil cream, 0.5% on your hands, clothing, carpeting or furniture. Laboratory Tests To rule out the presence of a frank neoplasm, a biopsy may be considered for those areas failing to respond to treatment or recurring after treatment.
Carcinogenesis, Mutagenesis, Impairment of Fertility Adequate long-term studies in animals to evaluate carcinogenic potential have not been conducted with fluorouracil. Studies with the active ingredient of fluorouracil cream, 0.5%, fluorouracil, have shown positive effects in in vitro and in vivo tests for mutagenicity and on impairment of fertility in in vivo animal studies. Fluorouracil produced morphological transformation of cells in in vitro cell transformation assays.
Morphological transformation was also produced in an in vitro assay by a metabolite of fluorouracil, and the transformed cells produced malignant tumors when injected into immunosuppressed syngeneic mice. Fluorouracil has been shown to exert mutagenic activity in yeast cells, Bacillus subtilis, and Drosophila assays. In addition, fluorouracil has produced chromosome damage at concentrations of 1.0 and 2.0 mcg/mL in an in vitro hamster fibroblast assay, was positive in a microwell mouse lymphoma assay, and was positive in in vivo micronucleus assays in rats and mice following intraperitoneal administration.
Some patients receiving cumulative doses of 0.24 to 1.0 g of fluorouracil parenterally have shown an increase in numerical and structural chromosome aberrations in peripheral blood lymphocytes. Fluorouracil has been shown to impair fertility after parenteral administration in rats. Fluorouracil administered at intraperitoneal doses of 125 and 250 mg/kg has been shown to induce chromosomal aberrations and changes in chromosome organization of spermatogonia in rats.
In mice, single-dose intravenous and intraperitoneal injections of fluorouracil have been reported to kill differentiated spermatogonia and spermatocytes at a dose of 500 mg/kg and produce abnormalities in spermatids at 50 mg/kg. Pediatric Use Actinic keratosis is not a condition seen within the pediatric population, except in association with rare genetic diseases. Fluorouracil cream, 0.5% should not be us… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Women It is not known whether fluorouracil is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from fluorouracil, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility Adequate long-term studies in animals to evaluate carcinogenic potential have not been conducted with fluorouracil. Studies with the active ingredient of fluorouracil cream, 0.5%, fluorouracil, have shown positive effects in in vitro and in vivo tests for mutagenicity and on impairment of fertility in in vivo animal studies. Fluorouracil produced morphological transformation of cells in in vitro cell transformation assays.
Morphological transformation was also produced in an in vitro assay by a metabolite of fluorouracil, and the transformed cells produced malignant tumors when injected into immunosuppressed syngeneic mice. Fluorouracil has been shown to exert mutagenic activity in yeast cells, Bacillus subtilis, and Drosophila assays. In addition, fluorouracil has produced chromosome damage at concentrations of 1.0 and 2.0 mcg/mL in an in vitro hamster fibroblast assay, was positive in a microwell mouse lymphoma assay, and was positive in in vivo micronucleus assays in rats and mice following intraperitoneal administration.
Some patients receiving cumulative doses of 0.24 to 1.0 g of fluorouracil parenterally have shown an increase in numerical and structural chromosome aberrations in peripheral blood lymphocytes. Fluorouracil has been shown to impair fertility after parenteral administration in rats. Fluorouracil administered at intraperitoneal doses of 125 and 250 mg/kg has been shown to induce chromosomal aberrations and changes in chromosome organization of spermatogonia in rats.
In mice, single-dose intravenous and intraperitoneal injections of fluorouracil have been reported to kill differentiated spermatogonia and spermatocytes at a dose of 500 mg/kg and produce abnormalities in spermatids at 50 mg/kg.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION Fluorouracil cream, 0.5% Carton Label NDC 75907-169-11 Container label carton Container