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Icy Hot by Lead Chemical Co. Ltd.

Dosage form: patch
Ingredients: LIDOCAINE 240mg, MENTHOL, UNSPECIFIED FORM 60mg
Labeler: Lead Chemical Co. Ltd.
NDC Code: 62168-1720

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.

Icy Hot Lidocaine Menthol Patch

Active ingredient

Lidocaine 4%
Menthol 1%

Purposes

Topical Anesthetic
Topical Analgesic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do Not Use
more than 1 patch on your body at a time or on cut, irritated or swollen skin
on puncture wounds
for more than one week without consulting a doctor

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 apply to wounds or damaged, broken or irritated skin
do not allow contact with the eyes and mucous membranes
do not bandage tightly or apply local heat (such as heating pads) to the area of use
do not use at the same time as other topical analgesics
dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

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 and Pets

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 12 years:

clean and dry affected area
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
use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Inactive Ingredients

aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methylparaben, PEG-40 hydrogenated castor oil, polyacrylic acid, polysorbate 80, propylene glycol, ricinus communis (castor) seed oil, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water

Package/Label Principal Display Panel

Icy Hot®

LIDOCAINE PATCH
PLUS MENTHOL

Desensitizes Aggravated Nerves

Numbs Away Pain
Penetrates To The Nerves
Fast Acting and Long Lasting
Easy to Apply and Remove

Wash and dry area before application.

Pain Relieving Ointment
on a Breathable Adhesive Pad

Contains 1 Patch
3-15/16” x 5-1/2” (10 cm x 14 cm) each

Label

ICY HOT 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-1720
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE240 mg
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM60 mg
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS 
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
GLYCERIN 
METHYLPARABEN 
PEG-40 CASTOR OIL 
POLYSORBATE 80 
PROPYLENE GLYCOL 
CASTOR OIL 
SILICON DIOXIDE 
TARTARIC ACID 
TITANIUM DIOXIDE 
UREA 
WATER 
Packaging
#Item CodePackage Description
1NDC:62168-1720-1400 POUCH in 1 CARTON
11 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/15/2017
Labeler - Lead Chemical Co. Ltd. (693727091)
Registrant - Lead Chemical Co. Ltd. (693727091)
Establishment
NameAddressID/FEIOperations
Lead Chemical Co. Ltd.693727091MANUFACTURE(62168-1720)
Establishment
NameAddressID/FEIOperations
Lead Chemical Co. Ltd.718216992MANUFACTURE(62168-1720)

 
Lead Chemical Co. Ltd.

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Medically reviewed on Sep 18, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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