FDA Label for Medirelief Hot
View Indications, Usage & Precautions
Medirelief Hot Product Label
The following document was submitted to the FDA by the labeler of this product Farla Medical Healthcare Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
Active ingredients(in each patch) | Purpose |
Capsaicin 0.025%........................................................................................................................................................ | Topical analgesic |
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with
- simple back aches
- arthritis
- strains
- sprains
Warnings
FOR EXTERNAL USE ONLY. Avoid contact with the eyes.
Do Not Use
- on wounds or damaged skin
- on a tight bandage
- with a heating pad
- on sensitive skin
- if allergic to any ingredients in this product
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: consult a doctor
Other Information
- store at room temperature 68-77°F (20-25°C)
- do not store in direct sunlight or expose to excessive heat and moisture
TAMPER EVIDENT: Do not use if pouch containing the patch is torn or broken.
Inactive Ingredients
hydrogenated poly (C6-20 olefin), mineral oil, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, styrene/isoprene copolymer
Manufactured For & Distributed By:
Manufactured for:
Farla International Ltd., Unit 2,
Staples Corner Business Park, 1000 North Circular Road,
London NW2 7JP
Tel +1 (844) 280-8400
[email protected] - www.farlainternational.com
Distributed by:
Platinum Care
240 52nd Street, Brooklyn, NY 11220
Tel: +1-718-435-2072
Pricipal Display Panel
MediRelief a Farla brand
Hot
Penetrating Pain
Relief Patch
Capsaicin 0.025%
TEMPORARY RELIEF OF
MINOR ACHES AND PAINS:
• ARTHRITIS
• BACKACHES
• SPRAINS
• STRAINS
1 Patch
(Large)
5.1 in. x 7.1 in.
(13 cm x 18 cm)
* Please review the disclaimer below.