Walgreen Cool N Heat Maximum Strength Pain Relieving Liquid
FDA Label NDC 0363-4837

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 Company for the product Walgreen Cool N Heat Maximum Strength Pain Relieving (NDC 0363-4837). 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 other, active ingredients, purpose, uses, warnings, when using this product, stop use and consult a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Flammable

  • ♦keep away from fire or flame

    • DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

Active Ingredients

Menthol 16%

Purpose

Topical analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with:

  • ♦simple backache
  • ♦arthritis
  • ♦strains
  • ♦bruises
  • ♦sprains

Warnings

For external use only. Test on a small patch of skin before applying generously.

When Using This Product

  • ♦use only as directed
  • ♦avoid contact with the eyes and mucous membranes
  • ♦do not apply to wounds or damaged skin
  • ♦do not bandage tightly
  • ♦do not use with heating pads or other heating devices
  • ♦if redness is present, discontinue use and consult a doctor
  • ♦if skin irritation occurs, discontinue use
  • ♦a transient burning sensation may occur upon application but generally disappears in several days

Stop Use And Consult A Doctor If

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

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 immediately.

Directions

adults and children 12 years of age and older:

  • ♦apply generously to affected area
  • ♦massage into painful area until thoroughly absorbed into skin
  • ♦repeat if necessary, but not more than 3 to 4 times daily
  • ♦IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

    • Children 12 years or younger: ask a doctor before use.

Other Information

store at room temperature

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., capsaicin, citric acid, glycerin, isopropyl myristate, propylene glycol, water.

Questions Or Comments?

1-866-925-4733

Principal Display Panel - 73 Ml Bottle Carton

Walgreens

• WALGREENS •
PHARMACIST RECOMMENDED†

Compare to the active ingredient in
Maximum Strength Icy Hot®††

Cool 'n
Heat

16% MENTHOL /
PAIN RELIEVING LIQUID

Maximum Strength

Roll On
No Mess

  • Pain relief therapy for
    arthritis, backache,
    muscle strains & sprains
  • Fast-acting formula
  • Roller ball applicator
    keeps hands clean
  • Stain free & quick drying

    • NOT ACTUAL SIZE

    2.5 FL OZ (73 mL)

    Principal Display Panel (73 mL Bottle Carton)

    Principal Display Panel (73 mL Bottle Carton)

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