Active Ingredient
Menthol 5%
Icy Hot Patch
FDA Label NDC 62168-0853
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lead Chemical Co., Ltd. for the product Icy Hot (NDC 62168-0853). 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 ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
Purpose
Topical analgesic
Uses
temporarily relieves minor pain associated with:
▪ arthritis▪ simple backache▪ bursitis▪ tendonitis▪ muscle strains▪ sprains▪ bruises▪ cramps
Warnings
For external use only
When Using This Product
▪ use only as directed. Read and follow all directions and warnings on this label.▪ avoid contact with eyes and mucous membranes▪ rare cases of serious burns have been reported with products of this type▪ do not apply to wounds or damaged, broken or irritated skin▪ do not bandage tightly or apply local heat (such as heating pads) to the area of use▪ a transient burning sensation may occur upon application but generally disappears in several days
Stop Use And Ask A Doctor If
▪ condition worsens▪ redness is present▪ irritation develops▪ symptoms persist for more than 7 days or clear up and occur again within a few days▪ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
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 and children over 12 years:
▪ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle▪ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area▪ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area▪ wear one Icy Hot patch for up to 8 hours▪ repeat as necessary, but no more than 3 times daily
children 12 years or younger: ask a doctor
Inactive Ingredients
aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water
Principal Display Panel - Back & Large Areas
MENTHOL 5%
ICY HOT®
ORIGINAL
Pain Relief Patch
LARGE
PATCH
FEEL IT WORKING
INSTANTLY
➢ Powerful Targeted Relief➢ Icy to Dull, Hot to Relax➢ Comfortable Fabric➢ Stays in Place
Wear For Up To 8 Hours
Contains 5 Patches in 1 Resealable Pouch
3-15/16” x 7-13/16” (10 cm x 20 cm) each
CHATTEM®
A SANOFI COMPANY
Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2020 www.icyhot.com
Pouch Label (Back and Large Areas)
Pouch Label - Back and Large Areas
Principal Display Panel - Back & Large Areas – Single Patch
MENTHOL 5%
ICY HOT®
ORIGINAL
Pain Relief Patch
LARGE
PATCH
FEEL IT WORKING
INSTANTLY
➢ Powerful Targeted Relief➢ Icy to Dull, Hot to Relax➢ Comfortable Fabric➢ Stays in Place
Wear For Up To 8 Hours
Contains 1 Patch
3-15/16” x 7-13/16” (10 cm x 20 cm)
CHATTEM®
A SANOFI COMPANY
Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2020 www.icyhot.com
Pouch Label (Back and Large Areas – Single Patch)
Pouch Label - Back and Large Areas – Single Patch
* Please review the disclaimer below.
