ICY HOT- lidocaine, menthol patch

Icy Hot by

Drug Labeling and Warnings

Icy Hot by is a Otc medication manufactured, distributed, or labeled by Lead Chemical Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ICY HOT 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-1720
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	240 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	60 mg

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CASTOR OIL (UNII: D5340Y2I9G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62168-1720-1	400 in 1 CARTON	01/15/2017
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/15/2017

Labeler - Lead Chemical Co. Ltd. (693727091)

Registrant - Lead Chemical Co. Ltd. (693727091)

Establishment
Name	Address	ID/FEI	Business Operations
Lead Chemical Co. Ltd.		693727091	MANUFACTURE(62168-1720)

Establishment
Name	Address	ID/FEI	Business Operations
Lead Chemical Co. Ltd.		718216992	MANUFACTURE(62168-1720)