Otc - Active Ingredient
Drug Facts
Active ingredient Purpose
Menthol 5%...........................................................................................Topical analgesic
Coralite Cool Pain Relief Patch 2 Ct Patch
FDA Label NDC 65923-589
13 label sections · Submitted to the FDA by United Exchange Corp · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp for the product Coralite Cool Pain Relief Patch 2 Ct (NDC 65923-589). 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, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, 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 associated with:
simple backache arthritis strains bruises sprains
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use
on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions
Ask a doctor before use if you have redness over the affected area.
Otc - When Using
When using this product
use only as directed
avoid contact with eyes and mucous membranes
do not bandage tightly
discontinue use at least 1 hour before a bath or shower
do not use immediately after a bath or shower
rare cases of serious burns have been reported with products of this type
Otc - Stop Use
Stop use and ask a doctor if
condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control Center (1-800-222-1222) right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Indications & Usage
Directions
adults and children 12 years of age and older:
open pouch and remove patch
carefully peel off protective backing and apply sticky side to affected area
apply to affected area no more than 3 to 4 times daily
wash hands after applying or removing patch. Throw away the patch by sticking
the ends together
children under 12 years of age: do not use, consult a doctor
Storage And Handling
Other information
store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
alcohol, aloe vera leaf, arnica montana flower, dihydroxyaluminum aminoacetate
anhydrous, gelatin, glycerin, kaolin, methylparaben, polyoxyl 40 stearate type I,
polysorbate 80, propylene glycol, propylparaben, purified water, sodium polyacrylate,
sorbitan monooleate, tartaric acid, titanium dioxide
Dosage & Administration
Questions or comments?
Call 1-888-645-8204 MONDAY-FRIDAY 9AM-5PM (PST)
*This product is not manufactured or distributed by RB Health (US),
distributor of Biofreeze® Pain Relief Patch.
Distributed by: UNITED EXCHANGE CORP.
Cypress, CA 90630 USA | 1-888-645-8204
Made in China
90222-ZDP-PH-R1
PR-TP-ZDP203-R1
Package Label.Principal Display Panel
90222 (90222)
* Please review the disclaimer below.
