Hielo Ardiente Gel
FDA Label NDC 53145-002

7 label sections · Submitted to the FDA by Menper Distributors, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors, Inc. for the product Hielo Ardiente (NDC 53145-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient

Menthol 1%

Otc - Purpose

Purpose

Analgesic

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.

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

In case of accidental ingestion, contact a doctor or a Poison Control Center right away.

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.

Inactive Ingredient

Inactive ingredients

camphor, carbomer 940, FD&C blue #1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, polysorbate 20, purified water, triethanolamine

* Please review the disclaimer below.