Walgreens Cool N Heat
FDA Label NDC 10889-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vvf Kansas Services Llc for the product Walgreens Cool N Heat (NDC 10889-201). 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 ingredients, 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 Ingredients

Methyl Salicylate 30%

Menthol 10%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor aches and pains associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

Warnings

For external use only.

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

Allergy Alert:

Do not use if allergic to salicylates (including aspirin) without consulting a physician.

When Using This Product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

Keep Out Of Reach Of Children.

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

Directions

Adults and Children 10 Years of Age or Older

  • Apply generously to affected area
  • Massage area until thoroughly absorbed into skin
  • Repeat as necessary, but no more than 4 times daily
    • Children Under 10 Years of Age Consult a doctor

Inactive Ingredient

Propylene Glycol, Sodium Stearate, Water, Stearic Acid, Cyclopentasiloxane, Hydrogenated Castor Oil, PEG-150 Distearate, Stearyl Alcohol.

Other

*This product is not manufactured or distributed by Chattem, Inc.Chattanooga, TN 37409.

Made in USA

Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015-4616

100% Satisfaction Guaranteed

www.wallgreens.com

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Compare to Icy Hot (R) Chill Stick active ingredients*

Walgreens

EXTRA STRENGTH

COOL 'N HEAT

Therapy Pain Relief Stick

NET WT 2 OZ (56.7G)


NDC 10889-201-11 (2 OZ)

Walgreens Cool 'n Heat Label (Walgreenscoolnheatlabel)

Walgreens Cool 'n Heat Label (Walgreenscoolnheatlabel)



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