Otc - Active Ingredient
Drug Facts
Active Ingredient Purpose
Menthol 8.0% Topical Analgesic
Extra Strength Stopain Cold Pain Relieving Roll On Liquid
FDA Label NDC 63936-8523
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Troy Manufacturing, Inc for the product Extra Strength Stopain Cold Pain Relieving Roll On (NDC 63936-8523). 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, indications & usage, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PurposeTopical Analgesic
Indications & Usage
Uses: For the temporary relief of minor aches and pains of muscle and joints associated with - simple backache -arthritis - strains - bruises -sprains
Warnings
Warnings
For external use only. Avoid contact with eyes.
Flammable: Keep away from fire or flame
Otc - When Using
When using this product
use only as directed
do not bandage tightly or use a heating pad
do not apply to wounds or damaged skin.
Otc - Stop Use
Stop use and ask a doctor if
condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
redness is present
excessive irritation of the skin develops.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, aska health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Adults and children over 12 years: spray directly onto affected area without the need to rub, massage or bandage
repeat as necessary, but do not apply more than 4 times daily.
Children 12 years or younger: ask a doctor.
Storage And Handling
Other information
Store at room temperature
Inactive Ingredient
Inactive Ingredients
Boswellia serrata extract, carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerin, peppermint oil, SD alcohol 39-C, triethanolamine, water
Other
Manufactured for: Troy Healthcare, LLC 130 Lions Drive, Hazleton, PA 18202
800-201-PAIN (7246)
www.stopain.com
Package Label.Principal Display Panel
NOTHING LASTS LONGER
EXTRA STRENGTH
STOPAIN COLD
NO-DRIP, NO-STAIN
PAIN RELIVING LIQUID ROLL-ON
Immediate, Penetrating Pain Relief From
Arthritis
Muscle Aches
Back Pain
3fl oz (88 ml)
Stopain. Exactly what it does. tm
Keeps hands clean
Light, pleasant scent
Non Greasy
Easy to use
Works on contact
Pharmacist recommended
Your purchase benefits the Arthritis Foundation
For every unit of Stopain(r) product sold, Troy Healthcare, LLC will donate a portion of the proceeds to the ARthrits Foundation with a minimum contribution of $25,000 to help people take control of arthritis. For information about arthritis, contact the Foundation at 800-283-7800 or www.arthritis.org.
Our pharmacist recommended formulas:
Work on contact
Provide long-lasting pain relief
For more information, visit www.stopain.com today
made in USA
To report a serious adverse event, contact (800) 201 PAIN (7246)
* Please review the disclaimer below.
