Active Ingredients (In Each Patch)
Glycol Salicylate 35mg
L-Menthol 35mg
Nopen Cool
FDA Label NDC 69365-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jw Holdings Corporation for the product Nopen Cool (NDC 69365-006). 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 active ingredients (in each patch), purpose, uses, warnings, do not use, ask a doctor before use if, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
Temporary relieves mild to moderate aches and pains of muscles and joints associated with:
■simple backache ■bruises ■sprains ■shoulder pains ■muscle pains ■arthritis
Warnings
For external use only
Do Not Use
■on the face or rashes ■wounds or damaged skin ■with a heating pad ■if you are allergic to salicylates
■when sweating (Such as from exercise or heat) ■on children under 12 years of age
Ask A Doctor Before Use If
■ you have redness over the affected area ■ pregnant or breast feeding
When Using This Product
■ wash hands after applying or removing patch. ■ avoid contact with eyes or mucous membranes. ■ if eye contact occurs, rinse thoroughly with water. ■ do not bandage tightly
Stop Use And Ask A Doctor If
■ rash, itching or skin irritation develops ■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days
Keep Out Of Reach Of Children
Package not child-resistant. Dispose of the used patches after folding sticky ends together. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
■ clean and dry affected area before applying
■ peel off protective backing and apply sticky side to affected area and leave in place for up to 8 to 12 hours
■ remove used patch from skin before applying a new patch
Other Information
■ store at 20℃ to 25℃ (68℉ to 77℉)
■ avoid storing product in direct sunlight
■ protect product from excessive moisture
■ some individuals may not experience pain relief until several hours after applying the patch
Inactive Ingredients
Acryl Adhesive, Nonwoven Polyester Fabric, Paper Release Liner, Rubber Adhesive, Vanillyl Butyl Ether
Questions Or Comments?
Call 1-562-281-5888 Monday-Friday 9AM-4PM ET
Distributed by: Jemian USA Inc
Principal Display Panel-5 Patches
JW Pharmaceutical
NOPEN
Cool
Neutral sensation type Glycol Salicylate/ L-Menthol
5 Patches
2.7 in x 3.9 in (7 cm x 10 cm)
* Please review the disclaimer below.
