ICY HOT MEDICATED, MICRO- menthol patch 
Lead Chemical Co. Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Icy Hot® Medicated Micro Patch

Active Ingredient

Menthol 7.5%

Purpose

Topical analgesic

Uses

temporarily relieves minor aches and pains 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
•
rare cases of serious burns have been reported with products of this type
•
do not bandage tightly or apply local heat (such as heating pads) to the area of use
•
avoid contact with eyes and mucous membranes
•
do not apply to wounds or damaged, broken or irritated skin
•
do not use at the same time as other topical analgesics
•
do not use more than 4 patches at a time

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:

•
gently fold patch in half and remove one side of backing. Apply exposed adhesive to the site of pain.
•
remove remaining film from the other side and finish applying to skin.
•
use on affected areas for up to 12 hours

children 12 years or younger: ask a doctor

Inactive Ingredients

glyceryl hydrogenated rosinate, hydrated silica, mineral oil, PEG-400, polyisobutene, styrene/isoprene copolymer

 

Distributed by Chattem, Inc.                        309-106
P.O. Box 2219, Chattanooga, TN 37409-0219 USA
©2014 Chattem, Inc.                      www.icyhot.com
Made in Japan.                                       0065509-01

Principal Display Panel – Micro Patch

ICY HOT®  

MEDICATED
MICRO PATCH

Menthol 7.5%

TARGETED
RELIEF 

•
Stiffness
•
Tension Points
•
Muscle Aches
•
Joint Pain
•
Arthritis

Back, Shoulder, Elbow,
Neck, Knee & Small Areas

Contains 24 Patches in 1 Resealable Pouch
2.56" x 1.65" (6.5 cm x 4.2 cm) each 

Carton Label Front

Carton Label - Micro Patch

ICY HOT  MEDICATED, MICRO
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0848
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM29.3 mg
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62168-0848-1180 in 1 BOX08/07/201402/28/2022
124 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/07/201402/28/2022
Labeler - Lead Chemical Co. Ltd. (693727091)
Registrant - Lead Chemical Co. Ltd. (693727091)

Revised: 7/2023
Document Id: 6430f9fb-9851-4942-8f93-9a7325b767bb
Set id: 82a1f0d8-d143-4621-bf6a-152051f3168b
Version: 4
Effective Time: 20230721
 
Lead Chemical Co. Ltd.