Icy Hot Patch
FDA Label NDC 62168-0210

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 62168-0210). 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, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Camphor 3%
Menthol 5%

Purpose

Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

  • ▪arthritis
  • ▪simple backache
  • ▪strains
  • ▪sprains
  • ▪bruises

Warnings

For external use only

Do Not Use

  • ▪on wounds or on irritated or damaged skin
  • ▪with a heating pad

When Using This Product

  • ▪use only as directed
  • ▪do not bandage tightly
  • ▪avoid contact with eyes and mucous membranes
  • ▪do not expose the area to local heat or to direct sunlight
  • ▪rare cases of serious burns have been reported with products of this type
  • ▪a transient burning sensation may occur upon application but generally disappears in several days
  • ▪avoid applying into skin folds

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
  • ▪redness is present or excessive skin irritation occurs
  • ▪you experience severe burning 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 12 years of age and older:

  • ▪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
  • ▪apply to affected area not more than 3 to 4 times daily
  • ▪wash hands after applying or removing patch. Throw away the patch by folding sticky ends together.

    • children under 12 years of age: ask a doctor

Inactive Ingredients

aluminum hydroxide, cellulose gum, disodium EDTA, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, talc, tartaric acid, titanium dioxide, water

Principal Display Panel – Pouch Label

ICY HOT®
 
PRO
PAIN RELIEF
PATCH
 
WEAR FOR UP
TO 8 HOUR
 
EXTRA STRENGTH WITH 2 PAIN RELIEVERS
 
MENTHOL 5%
CAMPHOR 3%
 
Contains 5 Patches in 1 Resealable Pouch
3-15/16" x 5-1/2" (10 cm x 14 cm) each
 
 
SANOFI CONSUMER HEALTH CARE
Dist. by: Chattem, Inc., a Sanofi Company
P.O. Box 2219, Chattanooga, TN 37409-0219 USA
©2022     www.icyhot.com

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Label

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