Iodoquinol, Hydrocortisone Acetate, Aloe Polysaccharides
FDA Drug Information • Also known as: Iodoquinol, Hydrocortisone Acetate, Aloe Polysaccharides
- Brand Names
- Iodoquinol, Hydrocortisone Acetate, Aloe Polysaccharides
- Route
- TOPICAL
- Dosage Form
- GEL
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION: Each gram contains 20 mg of hydrocortisone acetate, 10 mg of iodoquinol and 10 mg of aloe polysaccharides in a vehicle consisting of: amino methylpropanol 95%, benzyl alcohol, carbomer, citric acid anhydrous, D&C yellow #10, FD&C blue #1, glycerin, glyceryl polymethacrylate, magnesium aluminum silicate, palmitoyl oligopeptide, PPG-20 methyl glucose ether, propylene glycol, purified water, and SD Alcohol 40B. Hydrocortisone acetate is an anti-inflammatory and antipruritic agent. Chemically, hydrocortisone acetate is [Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-ß)-] with the molecular formula (C 23 H 32 O 6 ) and is represented by the following structural formula: Iodoquinol is an antifungal and antibacterial agent. Chemically, Iodoquinol is [5,7-diiodo-8-quinolinol] with the molecular formula (C 9 H 5 I 2 NO) and is represented by the following structural formula: Aloe polysaccharides are a concentrated, water soluble subcomponent of aloe vera with a mono-sugar ratio of Man : Gal : Glc: 40 : 1.4 : 1.0, linkage of 1-4 ß - linkage, O-Acetyl group of 25% of sugar units, and specific rotation of [α]D= -3.98° at 23.2°C. Average molecular weight is 80,000 daltons. Chemically, aloe polysaccharides is represented by the following structural formula: structure1 structure2 structure3
What Is Iodoquinol, Hydrocortisone Acetate, Aloe Polysaccharides Used For?
INDICATIONS: 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION: Apply to affected area(s) three to four times per day or as directed by a physician. Follow your physician’s directions regarding length of treatment after symptoms resolve.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae and miliaria.
Warnings and Precautions
WARNINGS: KEEP OUT OF REACH OF CHILDREN.
Contraindications
CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
How Supplied
HOW SUPPLIED: 1.69 oz. (48 g) tube, NDC 52187-545-48 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: KMM Pharmaceuticals, LLC 1000 N. West Street Suite 1200, #1201 Wilmington, DE 19801 2100006 [00] Rev. 01/2021
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.