Ireliev Roll On Cool Pain Relief Gel
FDA Label NDC 72909-014

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Excel Health, Inc for the product Ireliev Roll On Cool Pain Relief (NDC 72909-014). 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 active ingredient, indications:, warnings, keep out of reach of children, do not apply, if pregnant or breast feeding, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 6%

Indications:

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

Warnings

For external use only

  • Avoid contact with eyes
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children

If swallowed, consult physician

Do Not Apply

  • to wounds or damaged skin
  • Do not bandage tightly

If Pregnant Or Breast Feeding

contact physician prior to use

Directions

  • Adults and children two-years of age or older: Apply to affected area not more than three to four times dail
  • Children under two-years of age: consult a physician

Other Information

store at room temperature

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arctium Lappa (Burdock) Root Extract, Arnica Montana Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate’) Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Extract, Phenoxyethanol, Polysorbate- 20,  Tocopheryl Acetate (Vitamin E), Triethanolamine

Package Labeling:

Label2 (Label2)

Label2 (Label2)

* Please review the disclaimer below.