Drugplain

Icy Hot Medicated, XL 750 mg/1

Menthol · PATCH · Lead Chemical Co., Ltd.

No Recall History
Plain English

Icy Hot Medicated, XL is a patch containing menthol at 750 mg/1, taken topical. Manufactured by Lead Chemical Co., Ltd..

Key Facts

Brand Name
Icy Hot Medicated, XL
Generic Name
Menthol
NDC Code (Product)
62168-0847
Manufacturer
Lead Chemical Co., Ltd.
Strength
750 mg/1
Dosage Form
PATCH
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
12/01/2007

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective254 reports
no adverse event127 reports
pain118 reports
off label use98 reports
dyspnoea97 reports
fatigue95 reports
pruritus86 reports
dizziness79 reports
headache77 reports
diarrhoea73 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Icy Hot Arm, Neck and Leg Patches; and Icy Hot XL Patches temporarily relieves minor pain associated with: • arthritis • simple backache • bursitis • tendonitis • muscle strains • sprains • bruises • cramps

Dosage & Administration

Directions Icy Hot Arm, Neck and Leg Patches; and Icy Hot XL Patches adults and children over 12 years: • 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 • wear one Icy Hot patch for up to 8 hours • repeat as necessary, but no more than 3 times daily children 12 years or younger: ask a doctor

Warnings

Warnings For external use only When using this product Icy Hot Arm, Neck and Leg Patches; and Icy Hot XL Patches • use only as directed. Read and follow all directions and warnings on this label. • avoid contact with eyes and mucous membranes • 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 bandage tightly or apply local heat (such as heating pads) to the area of use • a transient burning sensation may occur upon application but generally disappears in several days Stop use and ask a doctor if Icy Hot Arm, Neck and Leg Patches; and Icy Hot XL Patches • 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.

Frequently Asked Questions

What is Icy Hot Medicated, XL used for?

Icy Hot Medicated, XL contains Menthol. It is a patch taken topical. Consult your doctor for specific uses.

Is Icy Hot Medicated, XL a controlled substance?

Icy Hot Medicated, XL is not classified as a controlled substance by the DEA.

What is the generic name for Icy Hot Medicated, XL?

The generic name for Icy Hot Medicated, XL is Menthol. There are 12 other brand versions of Menthol.

What is the NDC code for Icy Hot Medicated, XL 750 mg/1?

The NDC (National Drug Code) for Icy Hot Medicated, XL 750 mg/1 is 62168-0847, listed by Lead Chemical Co., Ltd..