The following Structured Product Label (SPL) was submitted to the FDA by Primus Pharmaceuticals for the product Aloquin (NDC 68040-706). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, description, iodoquinol, aloe polysaccharide, indications and usage, contraindications, warnings and precautions, carcinogenesis, mutagenisis and impairment of fertility, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Prescribing Information
Rx ONLY
www.aloquin.com
Manufactured for:
Primus Pharmaceuticals, Inc.
Scottsdale, AZ 85251
www.primusrx.com
Manufactured by:
Sonar Products, Inc.
Carlstadt, NJ 07072
U.S. Patents #6,436,679; #6,271,214; #6,133,440; #5,925,357; #5,902,796; #5,708,038; #5,703,060; #5,468,737; other patents pending.
©2009 Primus Pharmaceuticals, Inc. All rights reserved.
ISS.0309 #15905
Each gram of ALOQUIN contains 1.25% (12.5 mg) Iodoquinol and 1% (10mg) 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 #1 and D&C Yellow #10.
Iodoquinol 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:
Chemical Structure (Aloquin 01)
The Aloe Polysaccharide in ALOQUIN is a patented mixture of acetylated mannan aloe polysaccharide. Each purified acetylated mannan polysaccharide of specific molecular weight range and average is composed of the same repeating subunits shown below (where m is mannose, n is galactose and p is glucose monomers):
Chemical Structure (Aloquin 02)
Based on a review of a 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); monliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation.
ALOQUIN is contraindicated in those patients with a history of hypersensitivity to any components of the preparation.
For external use only. Keep away from eyes. If irritation develops, the use of ALOQUIN 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 a false positive result if Iodoquinol is present in the diaper or urine. Prolonged use may result in overgrowth of non-susceptible organisms requiring appropriate therapy. Keep out of reach of children.
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.
Animal reproductive studies have not been conducted with ALOQUIN. It is not known whether ALOQUIN can cause fetal harm when administered to pregnant women or can affect reproductive capacity. ALOQUIN should be given to pregnant women only if clearly needed.
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 ALOQUIN is administered to a nursing woman.
Safety and effectiveness in pediatric patients under the age of 12 have not been established.
Adverse reactions from topical use of ALOQUIN 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 a common daily oral dose of nearly 2,000 mg Iodoquinol, one will need to use more than 2 full tubes of 60 g ALOQUIN in a 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.
Apply to affected areas 3-4 times daily or as directed by a physician. Follow your physician's directions regarding length of treatment after symptoms resolve.
| NDC # 68040-706-16 | 60 gram gel tube |
| NDC # 68040-706-01 | 1 gram gel individual pack |
| NDC # 68040-706-08 | 10-count carton of 1 gram gel sample packs - not for resale |
Each 1 gram gel pack contains multiple doses depending on the surface area treated.
Store at room temperature 15°-30°C (59°-86°F). Keep tightly closed.
NDC 68040-706-16
AloQuin™ GEL
1.25% iodoquinol • 1% aloe polysaccharides
Contains Moisturizers • For Dermatological Use Only
Rx Only
Biopeptide Aloe Complex™
Deeper Penetration • Patented Formula
Net Wt. 60g
Principal Display Panel (60g Carton)
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