Gel Cooling Pain Relief

Manufacturer
Vi-Jon, LLC | Vi Jon, LLC
Effective date
2022-03-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:05:54

Label at a glance#

ProductGel Cooling Pain Relief
Active ingredientMENTHOL
Label structure12 sections

Dosage and administration

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

Storage and handling

store in a cool dry place with lid closed tightly

Label contents#

Full prescribing information#

Active ingrident

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

Flammable, keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

store in a cool dry place with lid closed tightly

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Adverse Reactions Section

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

Distributed by: Vi-Jon, LLC

St. Louis MO 63114

principal display panel

PACKAGE LABEL.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 descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0869-08940869-0894-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1520a4e9-8dfe-470e-e063-6394a90ac34ae922d6c7-9564-4588-9263-7d2b97a722732024-04-02Warnings, Adverse reactionsExact identifier
spl set id: e922d6c7-9564-4588-9263-7d2b97a72273

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.