Gel Cooling Pain Relief Gel
FDA Label NDC 11344-894

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Gel Cooling Pain Relief (NDC 11344-894). 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 ingrident, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingrident

Menthol 4%

Purpose

External analgesic

Uses

for temporary relief from minor aches and pains of muscles & joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Flammable, keep away from fire or flame.

When Using This Product

  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop Use And Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor

Other Information

store in a cool dry place with lid closed tightly

Inactive Ingredients

Aloe barbadensis leaf juice, Arctium lappa root extract, Arnica montana flower extract, blue 1, Boswellia carterii resin extract, Calendula officinalis flower extract, Camellia sinensis leaf extract, camphor, carbomer, Chamomilla recutita (matricaria) flower extract, glycerin, Ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, tocopheryl acetate, triethanolamine, water, yellow 5

Disclaimer

This product is not manufactured or distributed by Biofreeze Performance Health, distribtor of BioFreeze Cool the Pain Roll-On Fast Acting Menthol Pain Relief.

Adverse Reactions Section

Distributed by: Vi-Jon, LLC

St. Louis MO 63114

Principal Display Panel

swan ®

ROLL-ON COOLING PAIN RELIEF

PAIN RELIEVING GEL

soothing menthol

  • For arthritis, sore muscles, joints and back pain
  • Diminshing scent

    • Compare to Biofreeze ®Cool the Pain Roll-On Fast Acting Menthol Pain Relief*

    2.5 FL OZ (74 mL)

    Image Description (Mm01)

    Image Description (Mm01)

* Please review the disclaimer below.