RVP

Drug Catalog - Product Detail

CAPSICUM OLEORESIN - ARTHRITIS FORM. (CAPSAICIN) CRM 0.00025 2OZ

NDC Mfr Size Str Form
00536-2525-25 RUGBY LABORATORIES 60 0.025% CREAM
Product Image

PACKAGE FILES

Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Package Image
Generic Name
DICLOFENAC SODIUM, CAPSAICIN
Substance Name
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
Description
11 DESCRIPTION Diclofenac sodium 2% topical solution, contains diclofenac sodium, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug, and is available as a clear, colorless to faintly pink or orange solution for topical application. The chemical name is 2[(2,6-dichlorophenyl)amino]-benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C 14 H 10 Cl 2 NNaO 2 , and it has the following chemical structure. Each 1 gram of solution contains 20 mg of diclofenac sodium USP. The inactive ingredients: dimethyl sulfoxide (DMSO, 45.5% w/w), ethanol 96%, hydroxypropyl cellulose, propylene glycol and purified water. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Diclofenac Sodium Topical Solution, USP 2% w/w , is supplied as a clear, colorless to faintly pink or orange solution containing 20 mg of diclofenac sodium per gram of solution, in a white polypropylene-dose pump bottle with a cap. Each pump actuation delivers 20 mg of diclofenac sodium in 1 gram of solution. 112 g bottle NDC 81877-645-12 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
1. INDICATIONS AND USAGE Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s). Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s). (1)
Dosage and Administration
2. DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. The recommended dose is 2 pump actuations on each painful knee, 2 times a day. (2) Apply diclofenac sodium topical solution, to clean, dry skin. (2.1) Dispense 40 mg (2 pump actuations) directly onto the knee or first into the hand and then onto the knee. Spread evenly around front, back and sides of the knee. (2.1) Wash hands completely after administering the product. (2.2) Wait until the area is completely dry before covering with clothing or applying sunscreen, insect repellent, cosmetics, topical medications, or other substances. (2.2) Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s). (2.2) Do not get diclofenac sodium topical solution in your eyes, nose, or mouth (2.2) . 2.1 General Dosing Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5.2) ]. For relief of the pain of osteoarthritis (OA) of the knee(s), the recommended dose is 40 mg of diclofenac sodium (2 pump actuations) on each painful knee, 2 times a day. Apply diclofenac sodium topical solution to clean, dry skin. The pump must be primed before first use. Instruct patients to fully depress the pump mechanism (actuation) 4 times while holding the bottle in an upright position. This portion should be discarded to ensure proper priming of the pump. No further priming of the bottle should be required. After the priming procedure, diclofenac sodium topical solution is properly dispensed by completely depressing the pump 2 times to achieve the prescribed dosage for one knee. Deliver the product directly into the palm of the hand and then apply evenly around front, back, and sides of the knee. Application of diclofenac sodium topical solution in an amount exceeding or less than the recommended dose has not been studied and is therefore not recommended. 2.2 Special Precautions Avoid showering/bathing for at least 30 minutes after the application of diclofenac sodium topical solution to the treated knee. Wash and dry hands after use. Do not apply diclofenac sodium topical solution to open wounds. Avoid contact of diclofenac sodium topical solution with eyes and mucous membranes. Do not apply external heat and/or occlusive dressings to treated knees. Avoid wearing clothing over the diclofenac sodium topical solution-treated knee(s) until the treated knee is dry. Protect the treated knee(s) from natural and artificial sunlight. Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same knee you have just treated with diclofenac sodium topical solution. Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s). Do not use combination therapy with diclofenac sodium topical solution and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.