Walgreens Cool N Heat Patch Xl Patch
FDA Label NDC 0363-6672

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 Walgreens Cool N Heat Patch Xl (NDC 0363-6672). 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, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel - 5.51 In X 9.84 In Carton Label

Active Ingredient

Menthol 5%

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

Do Not Use

on wounds or on irritated or damaged skin
with a heating pad
if you are allergic to any ingredients of this product

When Using This Product

use only as directed
do not bandage tightly
avoid contact with the eyes or mucous membranes
do not expose the area to local heat or direct sunlight
a transient burning sensation may occur upon application but generally disappears in several days
avoid applying into skin folds

Stop Use And Ask A Doctor If

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
redness is present or excessive irritation occurs
you experience severe burning, pain, swelling, or blistering where the product is applied

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

Adults and children 12 years of age and older:
remove backing from patch by firmly grasping both ends and gently pulling until backing separates in the middle
place exposed portion of patch backing to affected area and press to skin
carefully remove the remaining film while pressing the patch firmly on the skin
use on affected area not more then 3 to 4 times daily.
use one patch per application
discard after use
reseal pouch after opening
wash hands after applying and removing patch
Chilren under 12 years of age: consult a physician

Other Information

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

Inactive Ingredients

Cellulose Gum, Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.