Equate Cool And Heat Patch
FDA Label NDC 49035-888

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Equate Cool And Heat (NDC 49035-888). 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, if pregnant or breast-feeding,, 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 5%

Purpose

Menthol - Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to

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

Warnings

For external use only

When Using This Product

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

Stop Use And Ask A Doctor If

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

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 and over: apply patch to affected area as needed but no more than 4 times daily
  • children under 12 years: ask a doctor
  • for easy application: grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates. Remove protective film while applying pad directly to site of pain.

Inactive Ingredients

carbomer homopolymer, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxypropyl cellulose, kaolin, partially neutralized polycrylate, polyvinyl alcohol, purified water, sorbitol solution, tartaric acid

Questions?

Call: 1-888-287-1915

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