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RX ITEM-Tolak 4% Cream 40Gm By Hill Dermaceuticals

NDC 28105-0421-40 UPC/GTIN No.3-28105-42140-8 Mfg.Part No.42140 FLUOROURACIL TOPICAL CREAMBRAND: TOLAK NDC: 28105-0421-40,28105042140 UPC: 3-28105-42140-8,328105421408 Hill Dermaceuticals IncOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Tolak 4% Cream 40Gm By Hill Dermaceuticals

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Item No.: RX475087 NDC No.28105042140 UPC No.:328105421408 NDC No.28105-0421-40 UPC/GTIN No.3-28105-42140-8 MPN 42140 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx475087 Tolak 4% Cream 40gm by Hill Dermaceuticals Item No.3475087 NDC No.28105042140 UPC No.328105421408 Other Name Tolak Therapeuti

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TOLAK- fluorouracil cream
HILL DERMACEUTICALS, INC.

1 INDICATIONS AND USAGE

Tolak (fluorouracil) Cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp.

2 DOSAGE AND ADMINISTRATION

Prior to application of Tolak Cream, wash, rinse, and dry the treatment areas. Apply Tolak Cream once daily in an amount sufficient to cover the lesions of the face, ears, and/or scalp with a thin film, using the fingertips to gently massage the medication uniformly into the skin. Apply Tolak Cream for a period of 4 weeks as tolerated. Thoroughly wash hands following Tolak Cream application.



Tolak Cream is for topical use only. Do not apply to eyes, nose, mouth or mucous membranes. Not for ophthalmic, oral or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Cream: 40 mg of fluorouracil per gram (4%) of white cream in 40 gram tubes.

4 CONTRAINDICATIONS

Tolak Cream is contraindicated:

During pregnancy [see Warnings and Precautions (5.5, 8.1)]
In patients with dihydropyrimidine dehydrogenase (DPD) deficiency.
WARNINGS AND PRECAUTIONS

5.1 Application Site Adverse Reactions
Application site reactions (erythema, scaling/dryness, edema, crusting, erosions, stinging/burning, and pruritus) were observed in almost all patients during treatment of actinic keratosis on the face, ears, and/or scalp with topical fluorouracil [see Adverse Reactions (6.1)]. In the clinical trials of Tolak Cream, application site irritation returned to baseline (pre-treatment) levels within 4 weeks after discontinuing treatment.

Do not apply Tolak Cream directly into eyes, nose, mouth, or other mucous membranes because irritation, local inflammation and ulceration can occur.
ADVERSE REACTIONS

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

Application Site Adverse Reactions [see Warnings and Precautions (5.1)]
Hypersensitivity Reactions [see Warnings and Precautions (5.2)]
Ophthalmic Adverse Reactions [see Warnings and Precautions (5.3)]
Photosensitivity [see Warnings and Precautions (5.4)]
Embryofetal toxicity [see Warnings and Precautions (5.5)]
Toxicity in Patients with Dihydropyrimidine Dehydrogenase Deficiency.
DESCRIPTION

Tolak (fluorouracil) Cream, 4% contains 40 mg of fluorouracil per gram of white cream for topical application. It is a nucleoside metabolic inhibitor. Chemically, fluorouracil is 5-fluoro-2,4 (1H,3H)-pyrimidinedione. The molecular formula of 5-fluorouracil is C4 H3 FN2 O2 , and its molecular weight is 130.1.
Tolak Cream contains the following inactive ingredients: arlacel-165, butylated hydroxytoluene, cetyl alcohol, anhydrous citric acid, glycerin, isopropyl myristate, methyl gluceth-10, methylparaben, propylparaben, purified water, peanut oil, sodium hydroxide, stearic acid, and stearyl alcohol. Tolak Cream formulation has an alkaline pH at 8.3 to 9.2.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
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 DNA and to a lesser extent inhibits the formation of 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.
Storage and Handling
Store at 25�C (77�F), with excursion permitted from 15�C to 30�C (59�F - 86�F) [See USP Controlled Room Temperature]. Do not freeze.

17 PATIENT COUNSELING INFORMATION

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

Important Administration Instructions

Advise patients of the following:

Tolak Cream is for external use only.
Do not apply to eyes, nose, mouth or mucous membranes.
Avoid inadvertent transfer of Tolak Cream to other body areas, or to another person.
Keep out of the reach of children.
Instruct patients to do the following:

Apply after washing, rinsing, and drying the treatment area.
Wash hands thoroughly after application.
Hypersensitivity Reactions

Inform patients that Tolak Cream contains peanut oil and that hypersensitivity reactions may occur with its use.
Inform patients to discontinue Tolak Cream immediately and seek medical attention if signs of severe hypersensitivity occur [see Warnings and Precautions (5.2)].
Ophthalmic Adverse Reactions

Inform patients that ophthalmic adverse reactions can occur with Tolak Cream use.
Advise patients that Tolak Cream is not for ophthalmic use.
Advise patients to avoid application around the eyes.
If accidental exposure occurs, advise patients to flush eye(s) with large amounts of water and seek medical care [see Warnings and Precautions (5.3)].
Increased Sensitivity to UV Light

Inform patients that topical fluorouracil is associated with photosensitivity reactions including severe sunburn.
Advise patients to minimize exposure to sun, sun lamps, and tanning beds while using Tolak Cream.
Advise patients that sunscreens may be applied after Tolak Cream application [see Warnings and Precautions (5.4)].
Embryofetal Toxicity

Inform females of reproductive potential of the potential risk to a fetus.
Advise females of reproductive potential to use effective contraception during and for one month after the last dose of Tolak Cream and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.5)].
Systemic Toxicity in Patients with DPD deficiency

Advise patient to stop using Tolak immediately and contact physician if abdominal (stomach) pain, bloody diarrhea, vomiting, fever, and/or chills occur with Tolak Cream use.
Inform patient that these symptoms could be manifestations of a deficiency in the enzyme dihydropyrimidine dehydrogenase (DPD) [see Warnings and Precautions (5.6)].
Manufactured and Distributed by:
Hill Dermaceuticals, Inc.
Sanford, Florida 32773

PATIENT INFORMATION Tolak (tol lak) (fluorouracil) Cream, 4%

Important: Tolak Cream is for use on skin only (topical). Do not get or apply Tolak Cream on your eyelids or in your eyes, nose, mouth, or in the vagina, because it may cause irritation and swelling in these areas.

What is Tolak Cream?

Tolak Cream is a prescription medicine used to treat skin lesions called actinic keratosis on the face, ears, or scalp.

It is not known if Tolak Cream is safe and effective for use on other areas of the body or to treat problems other than actinic keratosis.

It is not known if Tolak Cream is safe and effective in children.

Who should not use Tolak Cream?

Do not use Tolak Cream if:

you are pregnant or may become pregnant. Tolak Cream may harm your unborn child. Stop using Tolak Cream and tell your doctor right away if you become pregnant while using Tolak Cream.
your body does not make enough of (you are deficient in) the enzyme called dihydropyrimidine dehydrogenase (DPD). If you do not have enough of this enzyme, you may get serious side effects if you use Tolak Cream. Symptoms of serious side effects include: stomach-area abdominal pain, bloody diarrhea, vomiting, fever, and chills.
What should I tell my doctor before using Tolak Cream?

Before using Tolak Cream, tell your doctor about all your medical conditions, including if you:

are allergic to any of the ingredients in Tolak Cream. Tolak Cream contains peanut oil. See the end of this leaflet for a list of all of the ingredients in Tolak Cream.
are pregnant or plan to become pregnant. See "Who should not use Tolak Cream?"
Females who are able to become pregnant should use an effective method of birth control during treatment with Tolak Cream and for one month after the last dose of Tolak Cream. Talk to your doctor about birth control methods that may be right for you during treatment with Tolak Cream.
are breastfeeding or plan to breastfeed. It is not known if Tolak Cream passes into your breast milk. You and your doctor should decide if you will use Tolak Cream or breastfeed.
How should I use Tolak Cream?

Use Tolak Cream exactly as prescribed by your doctor.
Apply Tolak Cream 1 time each day, to the areas of your skin to be treated, for 4 weeks. Apply Tolak Cream as follows:
Gently wash, rinse, and pat dry the skin areas to be treated.
Apply a thin film of the Tolak Cream to the areas to be treated.
Gently massage Tolak Cream evenly into your skin.
Avoid contact with other areas of your body, and transfer of Tolak Cream from your body to other people.
Wash your hands well after you apply Tolak Cream.
What should I avoid while using Tolak Cream?

Do not cover the treated areas with an airtight dressing. � Avoid sunlight. Tolak Cream can make your skin sensitive to the sun. You could get severe sunburn. Limit your time in the sun during treatment with Tolak Cream. Talk to your doctor if you get sunburn.
What are the possible side effects of Tolak Cream?

Tolak Cream can cause serious side effects:

Skin reactions including possible allergic reactions. Most people using Tolak Cream get skin reactions in the treated areas. You may get skin reactions such as:
redness
dryness or scaling
crusting
itching
stinging or burning
swelling
skin loss (erosion)
Eye problems. Eye problems have happened with the use of medicines that contain fluorouracil that are applied to the skin. To help prevent getting Tolak Cream in your eyes, or transferring Tolak Cream from another part of your body to your eyes or to another person's eyes:
avoid applying Tolak Cream near or around your eyes
wash your hands well after you apply Tolak Cream
If you accidentally get Tolak Cream in your eyes, or if Tolak Cream is accidentally transferred to another person's eyes, flush eyes with large amounts of water and get medical help as soon as possible.

Tolak Cream can cause serious side effects in people who do not have enough of the enzyme dihydropyrimidine dehydrogenase (DPD). See "Who should not use Tolak Cream?" and "What should I tell my doctor before using Tolak Cream?" Stop using Tolak Cream and call your doctor right away if you get any of the following symptoms during treatment with Tolak Cream:
stomach-area (abdominal) pain
bloody diarrhea
vomiting
fever
chills
Tell your doctor if you get any of these skin reactions and they are severe or do not go away.

These are not all the possible side effects of Tolak Cream. 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 Tolak Cream?

Store Tolak Cream between 68�F to 77�F (20�C to 25�C).
Do not freeze Tolak Cream.
Do not use Tolak Cream after the expiration date printed on the tube.
Keep Tolak Cream and all medicines out of the reach of children.

General information about the safe and effective use of Tolak Cream

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tolak Cream for a condition for which it was not prescribed. Do not give Tolak Cream to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or doctor for information about Tolak Cream that is written for health professionals.

What are the ingredients in Tolak Cream?

Active ingredient: fluorouracil

Inactive ingredients: arlacel-165, butylated hydroxytoluene, cetyl alcohol, anhydrous citric acid, glycerin, isopropyl myristate, methyl gluceth-10, methylparaben, propylparaben, purified water, peanut oil, sodium hydroxide, stearic acid, and stearyl alcohol.

Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773

For more information, go to www.hillderm.com or call 1-800-344-5707.

This Patient Information has been approved by the U.S. Food and Drug Administration.
Issued: 09/2015

PRINCIPAL DISPLAY PANEL - 40 g Tube Carton

NDC 28105-421-40

Tolak� (fluorouracil) Cream 4%

Rx only

For Topical Use Only Not for Ophthalmic, Oral or Intravaginal Use

Contains Peanut Oil

40 g

Topical Cream

Hill Dermaceuticals, Inc.�

NDC 28105-0421-40 UPC/GTIN No.3-28105-42140-8 Mfg.Part No.42140 FLUOROURACIL TOPICAL CREAM
RX ITEM-Tolak 4% Cream 40Gm By Hill Derm
NDC 28105-0421-40 UPC/GTIN No.3-28105-42140-8 Mfg.Part No.42140 FLUOROURACIL TOPICAL CREAM

BRAND: TOLAK NDC: 28105-0421-40,28105042140 UPC: 3-28105-42140-8,328105421408 Hill Dermaceuticals Inc
Tolak 4% Cream 40Gm By Hill Dermaceutica
BRAND: TOLAK NDC: 28105-0421-40,28105042140 UPC: 3-28105-42140-8,328105421408 Hill Dermaceuticals Inc

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
Click above for Fluorouracil
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.