Drugplain

Hielo Ardiente 1 g/100g

Menthol · GEL · Menper Distributors, Inc.

No Recall History
Plain English

Hielo Ardiente is a gel containing menthol at 1 g/100g, taken topical. Manufactured by Menper Distributors, Inc..

Key Facts

Brand Name
Hielo Ardiente
Generic Name
Menthol
NDC Code (Product)
53145-002
Manufacturer
Menper Distributors, Inc.
Strength
1 g/100g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
02/21/2012

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use92 reports
drug ineffective82 reports
dyspnoea82 reports
fatigue81 reports
pain75 reports
pruritus72 reports
dizziness65 reports
cough64 reports
headache63 reports
drug hypersensitivity58 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises and sprains.

Dosage & Administration

Directions Adults and children 12 years of age or older: Apply to affected area no more than 3 to 4 times daily. Children under 12 years of age, consult a physician Cleanse and dry skin. May be used with wet or dry bandages in conjuction with ice packs.

Warnings

Warnings For external use only Avoid contact with eyes Do not use if condition worsens If symptoms persist for more than 5 days or recur, discontinue use and consult a physician Do not apply to open wounds or damaged skin Do not bandage tightly Do not use with heating pads or heating devices Use only as directed

Frequently Asked Questions

What is Hielo Ardiente used for?

Hielo Ardiente contains Menthol. It is a gel taken topical. Consult your doctor for specific uses.

Is Hielo Ardiente a controlled substance?

Hielo Ardiente is not classified as a controlled substance by the DEA.

What is the generic name for Hielo Ardiente?

The generic name for Hielo Ardiente is Menthol. There are 12 other brand versions of Menthol.

What is the NDC code for Hielo Ardiente 1 g/100g?

The NDC (National Drug Code) for Hielo Ardiente 1 g/100g is 53145-002, listed by Menper Distributors, Inc..