Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: 1 oz. tubes, NDC 52187-532-01 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, #1021 Wilmington, DE 19801 1800088 v1 Rev. 08/2018; carton
- HOW SUPPLIED: 1 oz. tubes, NDC 52187-532-01 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, #1021 Wilmington, DE 19801 1800088 v1 Rev. 08/2018
- carton
Overview
Each gram contains 10 mg of hydrocortisone and 10 mg of iodoquinol in a vehicle consisting of: aloe vera powder, aminomethyl propanol 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 40B alcohol. Chemically, hydrocortisone is [Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-,(11ß)-] with the molecular formula (C 21 H 30 O 5 ) and is represented by the following structural formula: and iodoquinol, 5,7-diiodo-8-quinolinol (C 9 H 5 I 2 NO) is represented by the following structural formula: Hydrocortisone is an anti-inflammatory and antipruritic agent, while iodoquinol is an antifungal and antibacterial agent. chem1 chem2
Indications & Usage
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); moniliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation.
Dosage & Administration
: Apply to affected area 3 to 4 times daily in accordance with physician’s directions.
Warnings & Precautions
WARNING: FOR EXTERNAL USE ONLY.
Contraindications
: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
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.
Storage & Handling
STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Keep container tightly closed. NOTICE: Protect from freezing and excessive heat.
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