Tacrolimus ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*, 26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3- methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19- epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. It has the following structural formula:

Tacrolimus has an empirical formula of C44H69NO12•H2O and a formula weight of 822.03. Each gram of tacrolimus ointment contains (w/w) 0.1% of tacrolimus in a base of mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax.

Mechanism of Action

The mechanism of action of tacrolimus in atopic dermatitis is not known. While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known. It has been demonstrated that tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This effect has been shown to prevent the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines (such as interleukin-2, gamma interferon). Tacrolimus also inhibits the transcription for genes which encode IL-3, IL-4, IL-5, GM-CSF, and TNF-α, all of which are involved in the early stages of T-cell activation. Additionally, tacrolimus has been shown to inhibit the release of pre-formed mediators from skin mast cells and basophils, and to down regulate the expression of FcεRI on Langerhans cells.

Pharmacokinetics

Absorption

The pooled results from three pharmacokinetic studies in 88 adult atopic dermatitis patients indicate that tacrolimus is minimally absorbed after the topical application of tacrolimus ointment. Peak tacrolimus blood concentrations ranged from undetectable to 20 ng/mL after single or multiple doses of 0.03% and 0.1% tacrolimus ointment, with 85% (75/88) of the patients having peak blood concentrations less than 2 ng/mL. In general as treatment continued, systemic exposure declined as the skin returned to normal. In clinical studies with periodic blood sampling, a similar distribution of tacrolimus blood levels was also observed in adult patients, with 90% (1,253/1,391) of patients having a blood concentration less than 2 ng/mL.

The absolute bioavailability of tacrolimus from tacrolimus ointment in atopic dermatitis patients is approximately 0.5%. In adults with an average of 53% BSA treated, exposure (AUC) of tacrolimus from tacrolimus ointment is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.

Mean peak tacrolimus blood concentrations following oral administration (0.3 mg/kg/day) in adult kidney transplant (n=26) and liver transplant (n=17) patients are 24.2±15.8 ng/mL and 68.5±30.0 ng/mL, respectively. The lowest tacrolimus blood level at which systemic effects (e.g., immunosuppression) can be observed is not known.

Systemic levels of tacrolimus have also been measured in pediatric patients (see Special Populations: Pediatrics).

Distribution

The plasma protein binding of tacrolimus is approximately 99% and is independent of concentration over a range of 5 to 50 ng/mL. Tacrolimus is bound mainly to albumin and alpha-1-acid glycoprotein, and has a high level of association with erythrocytes. The distribution of tacrolimus between whole blood and plasma depends on several factors, such as hematocrit, temperature at the time of plasma separation, drug concentration, and plasma protein concentration. In a US study, the ratio of whole blood concentration to plasma concentration averaged 35 (range 12 to 67).

There was no evidence based on blood concentrations that tacrolimus accumulates systemically upon intermittent topical application for periods of up to 1 year. As with other topical calcineurin inhibitors, it is not known whether tacrolimus is distributed into the lymphatic system.

Metabolism

Tacrolimus is extensively metabolized by the mixed-function oxidase system, primarily the cytochrome P-450 system (CYP3A). A metabolic pathway leading to the formation of 8 possible metabolites has been proposed. Demethylation and hydroxylation were identified as the primary mechanisms of biotransformation in vitro. The major metabolite identified in incubations with human liver microsomes is 13-demethyl tacrolimus. In in vitro studies, a 31-demethyl metabolite has been reported to have the same activity as tacrolimus.

Excretion

The mean clearance following IV administration of tacrolimus is 0.04, 0.083 and 0.053 L/hr/kg in healthy volunteers, adult kidney transplant patients and adult liver transplant patients, respectively. In man, less than 1% of the dose administered is excreted unchanged in urine.

In a mass balance study of IV administered radiolabeled tacrolimus to 6 healthy volunteers, the mean recovery of radiolabel was 77.8 ± 12.7%. Fecal elimination accounted for 92.4 ± 1.0% and the elimination half-life based on radioactivity was 48.1 ± 15.9 hours whereas it was 43.5 ± 11.6 hours based on tacrolimus concentrations. The mean clearance of radiolabel was 0.029 ± 0.015 L/hr/kg and clearance of tacrolimus was 0.029 ± 0.009 L/hr/kg.

When administered PO, the mean recovery of the radiolabel was 94.9 ± 30.7%. Fecal elimination accounted for 92.6 ± 30.7%, urinary elimination accounted for 2.3 ± 1.1% and the elimination half-life based on radioactivity was 31.9 ± 10.5 hours whereas it was 48.4 ± 12.3 hours based on tacrolimus concentrations. The mean clearance of radiolabel was 0.226 ± 0.116 L/hr/kg and clearance of tacrolimus 0.172 ± 0.088 L/hr/kg.

Special Populations

 Pediatrics 

In a pharmacokinetic study of 14 pediatric atopic dermatitis patients, between the ages of 2 to 5 years, peak blood concentrations of tacrolimus ranged from undetectable to 14.8 ng/mL after single or multiple doses of 0.03% tacrolimus ointment, with 86% (12/14) of patients having peak blood concentrations below 2 ng/mL throughout the study.

The highest peak concentration was observed in one patient with 82% BSA involvement on day 1 following application of 0.03% tacrolimus ointment. The peak concentrations for this subject were 14.8 ng/mL on day 1 and 4.1 ng/mL on day 14. Mean peak tacrolimus blood concentrations following oral administration in pediatric liver transplant patients (n = 9) were 48.4± 27.9 ng/mL.

In a similar pharmacokinetic study with 61 enrolled pediatric patients (ages 6 to 12 years) with atopic dermatitis, peak tacrolimus blood concentrations ranged from undetectable to 5.3 ng/mL after single or multiple doses of 0.1% tacrolimus ointment, with 91% (52/57) of evaluable patients having peak blood concentrations below 2 ng/mL throughout the study period. When detected, systemic exposure generally declined as treatment continued.

In clinical studies with periodic blood sampling, a similar distribution of tacrolimus blood levels was also observed, with 98% (509/522) of pediatric patients having a blood concentration below 2 ng/mL.

Renal Insufficiency

The effect of renal insufficiency on the pharmacokinetics of topically administered tacrolimus has not been evaluated. The mean clearance of IV administered tacrolimus in patients with renal dysfunction was similar to that of normal volunteers. On the basis of this information dose-adjustment is not expected to be needed.

Hepatic Insufficiency

The effect of hepatic insufficiency on the pharmacokinetics of topically administered tacrolimus has not been evaluated but dose-adjustment is not expected to be needed.

Three randomized, double-blind, vehicle-controlled, multi-center, phase 3 studies were conducted to evaluate tacrolimus ointment for the treatment of patients with moderate to severe atopic dermatitis. One (Pediatric) study included 351 patients 2 to 15 years of age, and the other two (Adult) studies included a total of 632 patients 15 to 79 years of age. Fifty-five percent (55%) of the patients were women and 27% were black. At baseline, 58% of the patients had severe disease and the mean body surface area (BSA) affected was 46%. Over 80% of patients had atopic dermatitis affecting the face and/or neck region. In these studies, patients applied either tacrolimus ointment 0.03%, tacrolimus Ointment 0.1%, or vehicle ointment twice daily to 10% to 100% of their BSA for up to 12 weeks.

In the pediatric study, a significantly greater (p < 0.001) percentage of patients achieved at least 90% improvement based on the physician’s global evaluation of clinical response (the pre-defined primary efficacy endpoint) in the tacrolimus ointment 0.03% treatment group compared to the vehicle treatment group, but there was insufficient evidence that tacrolimus ointment 0.1% provided more efficacy than tacrolimus ointment 0.03%.

In both adult studies, a significantly greater (p < 0.001) percentage of patients achieved at least 90% improvement based on the physician’s global evaluation of clinical response in the tacrolimus ointment 0.03% and tacrolimus ointment 0.1% treatment groups compared to the vehicle treatment group. There was evidence that tacrolimus ointment 0.1% may provide more efficacy than tacrolimus ointment 0.03%. The difference in efficacy between tacrolimus ointment 0.1% and 0.03% was particularly evident in adult patients with severe disease at baseline, adults with extensive BSA involvement, and black adults. Response rates for each treatment group are shown below by age groups. Because the two adult studies were identically designed, the results from these studies were pooled in this table.

Global Improvement over Baseline at the End-Of-Treatment in Three Phase 3 Studies

A statistically significant difference in the percentage of adult patients with ≥ 90% improvement was achieved by week 1 for those treated with tacrolimus ointment 0.1%, and by week 3 for those treated with tacrolimus ointment 0.03%. A statistically significant difference in the percentage of pediatric patients with ≥ 90% improvement was achieved by week 2 for those treated with tacrolimus ointment 0.03%.

In adult patients who had achieved ≥ 90% improvement at the end of treatment, 35% of those treated with tacrolimus ointment 0.03% and 41% of those treated with tacrolimus ointment 0.1%, regressed from this state of improvement at 2 weeks after end-of-treatment. In pediatric patients who had achieved ≥ 90% improvement, 54% of those treated with tacrolimus ointment 0.03% regressed from this state of improvement at 2 weeks after end-of-treatment. Because patients were not followed for longer than 2 weeks after end-of-treatment, it is not known how many additional patients regressed at periods longer than 2 weeks after cessation of therapy.

In both tacrolimus ointment treatment groups in adults and in the tacrolimus ointment 0.03% treatment group in pediatric patients, a significantly greater improvement compared to vehicle (p < 0.001) was observed in the secondary efficacy endpoints of percent body surface area involved, patient evaluation of pruritus, erythema, edema, excoriation, oozing, scaling, and lichenification. The following two graphs depict the time course of improvement in the percent body surface area affected in adult and in pediatric patients as a result of treatment.

Figure 1 - Adult Patients Body Surface Area Over Time

Figure 2 - Pediatric Patients Body Surface Area Over Time

The following two graphs depict the time course of improvement in erythema in adult and in pediatric patients as a result of treatment.

Figure 3 - Adult Patients Mean Erythema Over Time



Figure 4 - Pediatric Patients Mean Erythema Over Time

The time course of improvement in the remaining secondary efficacy variables was similar to that of erythema, with improvement in lichenification slightly slower.

Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.

Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGSand  PRECAUTIONS: Pediatric Use).

Tacrolimus ointment is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the ointment.

Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression.

Based on the information above and the mechanism of action, there is a concern about potential risk with the use of topical calcineurin inhibitors, including tacrolimus ointment. While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including tacrolimus ointment. Therefore:

• Tacrolimus ointment should not be used in immunocompromised adults and children.
• If signs and symptoms of atopic dermatitis do not improve within 6 weeks, patients should be re- examined by their healthcare provider and their diagnosis be confirmed (see PRECAUTIONS: General).
• The safety of tacrolimus ointment has not been established beyond one year of non-continuous use.

(See CLINICAL PHARMACOLOGY, boxed WARNING, INDICATIONS AND USAGE, and

DOSAGE AND ADMINISTRATION).

No phototoxicity and no photoallergenicity were detected in clinical studies with 12 and 216 normal volunteers, respectively. One out of 198 normal volunteers showed evidence of sensitization in a contact sensitization study.  

In three 12 week randomized vehicle-controlled studies and four safety studies, 655 and 9,163 patients respectively, were treated with tacrolimus ointment. The duration of follow-up for adult and pediatric patients in the safety studies is tabulated below.

Duration of Follow-up in Four Open-label Safety Studies

The following table depicts the adjusted incidence of adverse events pooled across the 3 identically designed 12-week controlled studies for patients in vehicle, tacrolimus ointment 0.03%, and tacrolimus ointment 0.1% treatment groups. The table also depicts the unadjusted incidence of adverse events in four safety studies, regardless of relationship to study drug.


Incidence of Treatment Emergent Adverse Events

* May be reasonably associated with the use of this drug product
† Generally “warts”.
‡ All the herpes zoster cases in the pediatric 12- week study and the majority of cases in the open- label pediatric studies were reported as chicken pox.

Other adverse events  which occurred at an incidence between 0.2% and less than 1% in clinical studies in the above table include: abnormal vision, abscess, anaphylactoid reaction, anemia, anorexia, anxiety, arthritis, arthrosis, bilirubinemia, blepharitis, bone disorder, breast neoplasm benign, bursitis, cataract NOS, chest pain, chills, colitis, conjunctival edema, constipation, cramps, cutaneous moniliasis, cystitis, dehydration, dizziness, dry eyes, dry mouth/nose, dyspnea, ear disorder, ecchymosis, edema, epistaxis, eye pain, furunculosis, gastritis, gastrointestinal disorder, hernia, hypercholesterolemia, hypertonia, hypothyroidism, joint disorder, laryngitis, leukoderma, lung disorder, malaise, migraine, moniliasis, mouth ulceration, nail disorder, neck pain, neoplasm benign, oral moniliasis, otitis externa, photosensitivity reaction, rectal disorder, seborrhea, skin carcinoma, skin discoloration, skin hypertrophy, skin ulcer, stomatitis, tendon disorder, thinking abnormal, tooth caries, sweating, syncope, tachycardia, taste perversion, unintended pregnancy, vaginal moniliasis, vaginitis, valvular heart disease, vasodilatation, and vertigo.

Post-Marketing Events
The following adverse reactions have been identified during postapproval use of tacrolimus ointment. 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.

CNS
Seizures

Neoplasms
Lymphomas, basal cell carcinoma, squamous cell carcinoma, malignant melanoma

Infections
Bullous impetigo, osteomyelitis, septicemia

Renal
Acute renal failure in patients with or without Netherton’s syndrome, renal impairment

Skin
Rosacea, application site edema

Tacrolimus ointment is not for oral use. Oral ingestion of tacrolimus ointment may lead to adverse effects associated with systemic administration of tacrolimus. If oral ingestion occurs, medical advice should be sought.

ADULT

Tacrolimus ointment 0.1%

• Apply a thin layer of tacrolimus ointment to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve.
• If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.
• Continuous long-term use of topical calcineurin inhibitors, including tacrolimus ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.

The safety of tacrolimus ointment under occlusion, which may promote systemic exposure, has not been evaluated. Tacrolimus ointment should not be used with occlusive dressings.

Tacrolimus ointment 0.1% is supplied in the following tube sizes:

Tacrolimus Ointment 0.1%

NDC21922-011-05

30 gram laminate tube

NDC21922-011-07

60 gram laminate tube

NDC21922-011-09

100 gram laminate tube

Store at room temperature 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

Manufactured by:

Encube Ethicals Pvt Ltd.

Plot No. C1, Madkaim Industrial Estate, Madkaim,

Post: Mardol, Ponda, Goa-403 404, India.

Distributed by:

Encube Ethicals, Inc.

200 Meredith Drive, Suite 202
Durham, NC 27713 USA

Rev: 10/23

Tacrolimus (ta kroe' li mus)

Ointment 0.1%

Read the Medication Guide every time you or a family member gets tacrolimus ointment. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. If you have questions about tacrolimus ointment, ask your doctor or pharmacist.

What is the most important information I should know about tacrolimus ointment?

The safety of using tacrolimus ointment for a long period of time is not known. A very small number of people who have used tacrolimus ointment have had cancer (for example, skin or lymphoma). However, a link with tacrolimus ointment has not been shown. Because of this concern:

• Do not use tacrolimus ointment continuously for a long time.
• Use tacrolimus ointment only on areas of your skin that have eczema.
• Do not use tacrolimus ointment on a child under 2 years old.

  Tacrolimus ointment comes in two strengths:

• Only tacrolimus ointment 0.03% is for use on children aged 2 to 15 years.
• Either tacrolimus ointment 0.03% or 0.1% can be used by adults and children 16 years and older.

Talk to your doctor for more information.

What is tacrolimus ointment?

Tacrolimus ointment is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis). Tacrolimus ointment is in a class of medicines called topical calcineurin inhibitors. It is for adults and children 2 years of age and older who do not have a weakened immune system. Tacrolimus ointment is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. Tacrolimus ointment is for use after other prescription medicines have not worked for you, or if your doctor recommends that other prescription medicines should not be used.

Who should not use tacrolimus ointment?

Tacrolimus ointment should not be used:

• on children younger than 2 years of age.
• if you are allergic to tacrolimus ointment or anything in it. See the end of this Medication Guide for a complete list of ingredients.

What should I tell my doctor before starting tacrolimus ointment?

Before you start using tacrolimus ointment, you and your doctor should talk about all of your medical conditions, including if you:

• have a skin disease called Netherton's syndrome (a rare inherited condition).
• have any infection on your skin including chicken pox or herpes.
• have been told you have a weakened immune system.
• are pregnant, breastfeeding, or planning to become pregnant.

Tell your doctor about all the medicines you take and skin products you use including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

How should I use tacrolimus ointment?

• Use tacrolimus ointment exactly as prescribed.
• Use tacrolimus ointment only on areas of your skin that have eczema.
• Use tacrolimus ointment for short periods, and if needed, treatment may be repeated with breaks in between.
• Stop tacrolimus ointment when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor.
• Follow your doctor’s advice if symptoms of eczema return after treatment with tacrolimus ointment.
• Call your doctor if:
  • your symptoms get worse with tacrolimus ointment. 
  • you get an infection on your skin.
  • your symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema.

To apply tacrolimus ointment:

• Wash your hands before applying tacrolimus ointment.
• Apply a thin layer of tacrolimus ointment twice daily to the areas of skin affected by eczema.
• Use the smallest amount of tacrolimus ointment needed to control the signs and symptoms of eczema.
• If you are a caregiver applying tacrolimus ointment to a patient, or if you are a patient who is not treating your hands, wash your hands with soap and water after applying tacrolimus ointment. This should remove any ointment left on the hands.
• Do not bathe, shower, or swim right after applying tacrolimus ointment. This could wash off the ointment.
• You can use moisturizers with tacrolimus ointment. Make sure you check with your doctor first about the products that are right for you. Because the skin of patients with eczema can be very dry, it is important to keep up good skin care practices. If you use moisturizers, apply them after tacrolimus ointment.

  What should I avoid while using tacrolimus ointment?

• Do not use ultraviolet light therapy, sun lamps, or tanning beds during treatment with tacrolimus ointment.
• Limit sun exposure during treatment with tacrolimus ointment even when the medicine is not on your skin. If you need to be outdoors after applying tacrolimus ointment, wear loose fitting clothing that protects the treated area from the sun. Ask your doctor what other types of protection from the sun you should use.
• Do not cover the skin being treated with bandages, dressings or wraps. You can wear normal clothing.
• Avoid getting tacrolimus ointment in the eyes or mouth. Do not swallow tacrolimus ointment. If you do, call your doctor.

What are the possible side effects of tacrolimus ointment?

Please read the first section of this Medication Guide.

The most common side effects of tacrolimus ointment at the skin application site are stinging, burning, or itching of the skin treated with tacrolimus ointment. These side effects are usually mild to moderate, are most common during the first few days of treatment, and usually go away as your skin heals.

Other side effects include acne, swollen or infected hair follicles, headache, increased sensitivity of the skin to hot or cold temperatures, or flu-like symptoms such as the common cold and stuffy nose, skin tingling, upset stomach, muscle pain, swollen glands (enlarged lymph  nodes), or skin infections including cold sores, chicken pox or shingles.

Talk to your doctor if you have a skin infection or if side effects (for example, swollen glands) continue or bother you.

While you are using tacrolimus ointment, drinking alcohol may cause the skin or face to become flushed or red and feel hot.

These are not all the side effects with tacrolimus ointment. Ask your doctor or pharmacist for more information.

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 tacrolimus ointment?

• Store tacrolimus ointment at room temperature (59oto 86oF). Do not leave tacrolimus ointment in your car in cold or hot weather. Make sure the cap on the tube is tightly closed.
• Keep tacrolimus ointment and all medicines out of the reach of children.

General advice about tacrolimus ointment

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use tacrolimus ointment for a condition for which it was not prescribed. Do not give tacrolimus ointment to other people, even if they have the same symptoms you have. It may not be right for them.

This Medication Guide summarizes the most important information about tacrolimus ointment. If you would like more information, talk with your doctor. Your doctor or pharmacist can give you information about tacrolimus ointment that is written for health care professionals. For more information, you can call: 1-833-285-4151

What are the ingredients in tacrolimus ointment?
Active Ingredient:tacrolimus.
Inactive Ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum and white wax.

Manufactured by:

Encube Ethicals Pvt Ltd.

Plot No. C1, Madkaim Industrial Estate, Madkaim,

Post: Mardol, Ponda, Goa-403 404, India.

Distributed by:

Encube Ethicals, Inc.

200 Meredith Drive, Suite 202
Durham, NC 27713 USA

This Medication Guide has been approved by the U.S. Food and Drug Administration

Rev: 10/23

Draft Carton Label - 30g

NDC 21922-011-05

Tacrolimus Ointment 0.1%

Attention: Dispense the accompanying Medication Guide to each patient.

FOR DERMATOLOGIC USE ONLY.

Not for ophthalmic use.

30 g
Rx only

Draft Carton Label - 60g

NDC 21922-011-07

Tacrolimus Ointment 0.1%

Attention: Dispense the accompanying Medication Guide to each patient.

FOR DERMATOLOGIC USE ONLY.

Not for ophthalmic use.

60 g

Rx only

Draft Carton Label - 100g

NDC 21922-011-09

Tacrolimus Ointment 0.1%

Attention: Dispense the accompanying Medication Guide to each patient.

FOR DERMATOLOGIC USE ONLY.

Not for ophthalmic use.

100 g

Rx only

Draft Container Label - 30g

NDC 21922-011-05

Tacrolimus Ointment 0.1%

Attention: Dispense the accompanying Medication Guide to each patient.

FOR DERMATOLOGIC USE ONLY.

Not for ophthalmic use.

30 g

Rx only

Draft Container Label - 60g

NDC 21922-011-07

Tacrolimus Ointment 0.1%

Attention: Dispense the accompanying Medication Guide to each patient.

FOR DERMATOLOGIC USE ONLY.

Not for ophthalmic use.

60 g

Rx only

Draft Container Label - 100g

NDC 21922-011-09

Tacrolimus Ointment 0.1%

Attention: Dispense the accompanying Medication Guide to each patient.

FOR DERMATOLOGIC USE ONLY.

Not for ophthalmic use.

100 g

Rx only