Cold Therapy Pain Relief Gel
FDA Label NDC 0363-0356

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Cold Therapy Pain Relief (NDC 0363-0356). 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, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 4%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame.

When Using This Product

  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop Use And Ask A Doctor If

  • you experience pain, swelling or blistering oi the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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: rub a thin film over affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • wash hands after use with cool water

Other Information

  • store at 20-25°C (68-77°F)
  • store in a cool dry place away from direct sunlight

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana (Arnica Flower) Extract, Boswellia Serrata Extract, Calendula Officinalis (Calendula) Flower Extract, Camellia Sinensis (Green Tea) Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Organic Ilex Paraguanensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water.

Principal Display Panel – 74 Ml Bottle Label

Walgreens

Compare to the active ingredient
in Biofreeze® Roll-On††

WALGREENS PHARMACIST RECOMMENDED

Cold Therapy
Pain Relief

MENTHOL 4% / TOPICAL ANALGESIC

Roll On

Cooling Pain Relief

  • For the temporary relief of arthritis,
    back pain, sore muscles & joints
  • Soothing menthol
  • Paraben free

    • 2.5 FL OZ (74 ml)

    Principal Display Panel – 74 mL Bottle Label (Wal09 0000 01)

    Principal Display Panel – 74 mL Bottle Label (Wal09 0000 01)

Principal Display Panel – 89 Ml Tube Label

Walgreens

Compare to the active
ingredient in Biofreeze® Gel††

WALGREENS PHARMACIST RECOMMENDED

Cold
Therapy
Pain Relief
Gel

MENTHOL 4% / TOPICAL ANALGESIC

Cooling Pain Relief

  • For the temporary relief of arthritis,
    back pain, sore muscles & joints
  • Soothing menthol
  • Paraben free

    • 3 FL OZ (89 ml)

    Principal Display Panel – 89 mL Tube Label (Wal09 0000 02)

    Principal Display Panel – 89 mL Tube Label (Wal09 0000 02)

* Please review the disclaimer below.