Otc - Active Ingredient
Active Ingredients Purpose
Methyl nicotinate 0.5% External Analgesic
Capsaicin 0.025 % External Analgesic
Arth Rx Topical Analgesic Lotion
FDA Label NDC 76069-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hcd Sales for the product Arth Rx Topical Analgesic (NDC 76069-100). 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 otc - active ingredient, otc - purpose, warnings, indications & usage, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses: Temporarily relieves minor aches and pains of muscles and joints due to:
- Arthritis - Strains - Sprains
Warnings
WARNINGS
FOR EXTERNAL USE ONLY
Indications & Usage
When Using This Product
- Avoid contact with eyes
- Do not apply to wounds or damaged skin
- Do not bandage tightly
Otc - Stop Use
Stop use and ask doctor if
- Condition worsens
- Excessive irritation of the skin develops
- Pain persists for more than 7 days
- Symptoms clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact a poison control center immediately.
Dosage & Administration
Directions
- Adults apply to affected area no more than 3-4 times daily
- Children under 18 consult a physician
- Apply to small area of the skin as test for sensitivity at least 60 minutes prior to applying to wide area.
Inactive Ingredient
Inactive Ingredients
Isopropanol, water, extracts of arnica and rue, polyacrylamide, C 13-14 isoparaffin. tween 80, laureth-7, boswellia, extract of chamomile, aloe, fragrance.
Otc - Questions
Questions or comments
Toll free 1-800-729-8446
Description
Products containing capsaicin may cause a burning, stinging or tingling sensation where applied. This is a natural reaction and varies with each individual usually decreasing or disappearing after continued use. Please read package insert prior to use. .......... may be removed from the test area by wiping or olive oil.
Distributed by:
HCD sales, Inc,
Tampa, FL 33549
www.hcdsales.com
Package Label.Principal Display Panel
arth.Rx TOPICAL ANALGESIC ARTHRITIS PAIN RELIEF PENETRATING PAIN RELIEF, DOUBLE ACTION FORMULA WITH DOCTOR RECOMMENDED CAPSAICIN NEW WT 3 OZ (85 g)
Arth Rx Topical Analgesic (Arthrxtopicalanalgesic)
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