ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS. Adverse reactions from topical use of QUINJA is expected to be low when used as directed, due to low concentration of Iodoquinol present in this topical gel.To achieve the equivalent of common daily oral dose of nearly 2,000 mg Iodoquinol, one will need to use more than full tubes of 60 QUINJA in single application. Adverse reactions from oral form of Iodoquinol (nearly 2,000 mg daily) have been reported: various forms of skin eruptions, hives, itching, nausea, vomiting, abdominal cramps, diarrhea, anusitis, fever, chills, headache, vertigo and enlargement of thyroid.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.


Carcinogenesis, Mutagenisis and Impairment of Fertility:. Long-term animal studies have not been performed to evaluate the carcinogenic potential of the effect on fertility of Iodoquinol. Mutagenicity studies have not been performed with Iodoquinol.

CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS. QUINJA is contraindicated in those patients with history of hypersensitivity to any components of the preparation.

DESCRIPTION SECTION.


DESCRIPTION. Each gram of QUINJA contains 1.25% (12.5 mg) Iodoquinol and 1% (10 mg) Aloe Polysaccharides. Other ingredients: Purified Water, Carbomer 980, Magnesium Aluminum Silicate, PEG-20 Methyl Glucose Ether, Aminomethyl Propanol 95, Biopeptide, Propylene Glycol, Glycerine, SDA Alcohol 40 B, Benzyl Alcohol, Trolamine, FD&C Blue and D&C Yellow 10.IodoquinolIodoquinol is an antifungal and antibacterial agent. Chemically, Iodoquinol is [5,7-diiodo-8-quinolinol] with the molecular formula (C9H5I2NO) and is represented by the following structural formula:Aloe PolysaccharideThe Aloe Polysaccharide in QUINJA is patented mixture of acetylated mannan aloe polysaccharide mixture with average molecular weights of 80 and 1300 kDa (CAS 89191- 46-8). Each purified acetylated mannan polysaccharide of specific molecular weight range and average is composed of the same repeating subunits shown below (where is mannose, is galactose and is glucose monomers):. structural formula for Iodoquinol. Aloe Polysaccharide.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION. Apply to affected areas 3-4 times daily or as directed by physician. Follow your physicians directions regarding length of treatment after symptoms resolve.

HOW SUPPLIED SECTION.


HOW SUPPLIED. NDC 69646-716-60......60 gram gel tubeNDC 69646-716-01......1 gram gel individual pack NDC 69646-716-10......10-count carton of gram gel sample packs not for resaleNDC 69646-716-02...... gram gel individual tube NDC 69646-716-11...... 10-count carton of gram gel sample tubes not for resaleEach gram gel pack contains multiple doses depending on the surface area treated.Each gram gel tube contains multiple doses depending on the surface area treated.

INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE. Based on review of related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: Possibly Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); moniliasis; intertrigo. Final classification of the less-than- effective indications requires further investigation.

NURSING MOTHERS SECTION.


Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when QUINJA is administered to nursing woman.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL. NDC 69646-716-60QUINJA gel1.25% iodoquinol 1% aloe polysaccharidesRx OnlyNet Wt. 60g NDC 69646-716-60QUINJA gel1.25% iodoquinol 1% aloe polysaccharidesRx OnlyNet Wt. 60g.

PEDIATRIC USE SECTION.


Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.

PREGNULLNCY SECTION.


Pregnancy Category C: Animal reproductive studies have not been conducted with QUINJA. It is not known whether QUINJA can cause fetal harm when administered to pregnant women or can affect reproductive capacity. QUINJA should be given to pregnant women only if clearly needed.

SPL UNCLASSIFIED SECTION.


Prescribing Information QUINJA(TM) gel(1.25% iodoquinol and 1% aloe polysaccharides).

STORAGE AND HANDLING SECTION.


STORAGE. Store at 20C to 25C (68F to 77F), excursions permitted between 15C and 30C (between 59F and 86F).Brief exposure to temperatures up to 40C (104F) may be tolerated provided the mean kinetic temperature does not exceed 25C (77F); however, such exposure should be minimized.Distributed by: Novum Pharma, LLC Chicago, IL 60606(C)2018 Novum Pharma, LLC. All rights reserved. QUI-022018-003.

WARNINGS AND PRECAUTIONS SECTION.


WARNINGS AND PRECAUTIONS. For external use only. Keep away from eyes. If irritation develops, the use of QUINJA should be discontinued and appropriate therapy instituted. Some discoloration of the skin, hair and fabrics may occur, but can be removed with normal cleansing and laundry. Not intended for use on infants or under diapers or occlusive dressings.Iodoquinol may be absorbed through the skin and interfere with thyroid function tests. If such tests are contemplated, wait at least one month after discontinuance of therapy to perform these tests. The ferric chloride test for phenylketonuria (PKU) can yield false positive result if Iodoquinol is present in the diaper or urine. Prolonged use may result in over- growth of non-susceptible organisms requiring appropriate therapy. Keep out of reach of children.. Carcinogenesis, Mutagenisis and Impairment of Fertility:. Long-term animal studies have not been performed to evaluate the carcinogenic potential of the effect on fertility of Iodoquinol. Mutagenicity studies have not been performed with Iodoquinol.. Pregnancy Category C: Animal reproductive studies have not been conducted with QUINJA. It is not known whether QUINJA can cause fetal harm when administered to pregnant women or can affect reproductive capacity. QUINJA should be given to pregnant women only if clearly needed.. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when QUINJA is administered to nursing woman.. Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.