FDA Label for Icy Hot
View Indications, Usage & Precautions
Icy Hot Product Label
The following document was submitted to the FDA by the labeler of this product Lead Chemical Co. Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
* Please review the disclaimer below.