Overnight Cold Therapy Pain Relief Gel
FDA Label NDC 0363-0355

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 Overnight Cold Therapy Pain Relief (NDC 0363-0355). 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 of 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 Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, Fragrance, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water

Principal Display Panel – 74 Ml Bottle Label

Walgreens

WALGREENS
PHARMACIST RECOMMENDED

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

OVERNIGHT
Cold Therapy
Pain Relief

MENTHOL 4%/TOPICAL ANALGESIC

Roll On

No Mess

  • For arthritis, back pain,
    sore muscles & joints
  • Soothing menthol
  • Paraben free

    • Lavender
    scent

    2.5 FL OZ (74 mL)

    Principal Display Panel – 74 mL Bottle Label (Wal0a 0001 01)

    Principal Display Panel – 74 mL Bottle Label (Wal0a 0001 01)

Principal Display Panel – 89 Ml Tube Label

Walgreens

WALGREENS
PHARMACIST RECOMMENDED

Compare to the active ingredient
in Biofreeze® Overnight Gel††

OVERNIGHT
Cold
Therapy
Pain Relief
Gel

MENTHOL 4%/TOPICAL ANALGESIC

  • For arthritis, back pain,
    sore muscles & joints
  • Soothing menthol
  • Paraben free

    • Lavender
    scent

    3 FL OZ (89 mL)

    Principal Display Panel – 89 mL Tube Label (Wal0a 0001 02)

    Principal Display Panel – 89 mL Tube Label (Wal0a 0001 02)

* Please review the disclaimer below.